Flow cytometry useful alternative to microscopy for differentiation of bronchoalveolar lavage fluid leukocytes: Study

Flow cytometry useful alternative to microscopy for differentiation of bronchoalveolar lavage fluid leukocytes suggests a study published in the Chest.

Microscopy is currently the gold standard to differentiate BAL fluid (BALF) leukocytes. However, local expertise for microscopic BALF leukocyte differentiation is often unavailable in clinical practice. A new automated flow cytometric method for BALF leukocyte differentiation, using four antibodies (anti-CD45, anti-CD66b, anti-HLA-DR, anti-CD52) given to human BALF in one tube, was developed and prospectively validated in 745 unselected, subsequent BALF samples from patients with interstitial lung diseases (455 patients), infectious diseases (196 patients), and other diseases (94 patients). Flow cytometry and traditional microscopy were performed by separate investigators in a double-blind fashion. Results were compared using Spearman`s correlation, Deming regression, and Bland-Altman analysis. Results: There was a strong correlation between flow cytometric and microscopic results regarding macrophage/monocyte, lymphocyte, eosinophil, and neutrophil percentages in BALF (P < .001 for all leukocyte subpopulations). Bland-Altman analyses showed that the mean differences between the methods were ≤2% for all four cell types. Flow cytometric results differed less than 20% from microscopic results in more than 95% of all samples. Subgroup analyses confirmed that these results were independent from total leukocyte counts in BALF. They report the first validated flow cytometric method for BALF leukocyte differentiation, which can be used in clinical settings where local expertise for microscopic analysis is unavailable and which can be combined easily with lymphocyte surface marker analysis.

Reference:

Bratke K, Weise M, Stoll P, Virchow JC, Lommatzsch M. Flow Cytometry as an Alternative to Microscopy for the Differentiation of BAL Fluid Leukocytes. Chest. 2024 Mar 26:S0012-3692(24)00426-4. doi: 10.1016/j.chest.2024.03.037. Epub ahead of print. PMID: 38548099.

Keywords:

Flow cytometry, alternative, microscopy, differentiation, bronchoalveolar, lavage fluid leukocytes, Study, Bratke K, Weise M, Stoll P, Virchow JC, Lommatzsch M, BAL fluid; flow cytometry; leukocytes; microscopy.

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ACP finds only one of eight measures to be valid for management of major depressive disorder

USA: The American College of Physicians (ACP) has released a review of performance measures designed to evaluate the quality of care for those with major depressive disorder (MDD). They found only one of eight measures relevant to internal medicine physicians to be valid.

The paper, published in Annals of Internal Medicine, presents a review of MDD performance measures and highlights opportunities to improve performance measures addressing MDD management.

Major depressive disorder is a severe mood disorder affecting at least 8.4% of the adult population in the United States. Characteristics of MDD include diminished interest in daily activities, persistent sadness, and a state of hopelessness.

The illness, if left untreated, may progress quickly and have devastating consequences. Eight performance measures are available to evaluate screening, diagnosis, and successful management of MDD. However, many performance measures fail to meet the criteria for reliability, validity, evidence, and meaningfulness. 

A January 2023 ACP clinical guideline recommends monotherapy with cognitive behavioral therapy (CBT) or with a second-generation antidepressant as an initial treatment in patients in the acute phase of moderate to severe MDD. There is strong evidence around appropriate treatment for MDD after an initial diagnosis, despite this, no performance measures currently exist to fill this gap. However, there are feasibility challenges with the data needed for such a performance measure, including but not limited to ICD-10 coding and capturing CBT recommendations.

The ACP’s Performance Measurement Committee (PMC) reviews performance measures using a validated process to inform regulatory and accreditation bodies in an effort to recognize high-quality performance measures, address gaps and areas for improvement in performance measures, and help reduce reporting burden.

ACP’s PMC found that out of eight performance measures only one measure, Suicide Risk Assessment, was found to be valid at all levels of attribution. This performance measure evaluates the frequency of suicide risk assessment for patients with a new diagnosis of major depressive disorder. The performance measure is evidence-based, clinically sound, and tested appropriately with reliable and valid results.

“It is important to screen, diagnose, and provide timely treatment for MDD,” Omar T. Atiq, M.D., MACP, president, ACP, said in a press release. “Performance measures intend to encourage evidence-based care with results that will drive improvements in care. However, several feasibility barriers related to continuity of care and coding need addressing to measure appropriate management of MDD accurately.”

There is a need for systemwide technological improvements to extract the necessary data and support proper coding for MDD management. The paper suggests that the need for data interoperability to improve reporting for performance measures that can move the quality needle and reduce the burden of performance measurement on group practices, physicians, and health systems.

Reference:

Qaseem A, Andrews RA, Campos K, Goldzweig CL, MacDonald S, McLean RM, Powell RE, Fitterman N; Performance Measurement Committee of the American College of Physicians*. Quality Indicators for Major Depressive Disorder in Adults: A Review of Performance Measures by the American College of Physicians. Ann Intern Med. 2024 Mar 5. doi: 10.7326/M23-3077. Epub ahead of print. PMID: 38437692.

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Revolutionary chronic wound treatment could help millions, reveals study

An effective treatment for chronic wounds that does not involve antibiotics, but an ionised gas to activate a wound dressing, has been developed by a team of international scientists.

The treatment involves the plasma activation of hydrogel dressings (that are commonly used in wound dressings) with a unique mix of different chemical oxidants that are effective in decontaminating and aid healing in chronic wounds.

Researchers from the University of Sheffield and University of South Australia, who led the study, believe the new method is a significant advance in tackling antibiotic resistance pathogens and has the potential to change the treatment of diabetic foot ulcers and internal wounds.

Professor Rob Short, Professor of Chemistry at the University of Sheffield who co-authored the study, said: “More than 540 million people are living with diabetes worldwide, of which 30 per cent will develop a foot ulcer during their lifetime. This is a neglected global pandemic which is set to increase further in the coming years due to a rise in obesity and lack of exercise.

“In England alone between 60,000 and 75,000 people are being treated for diabetic foot ulcers per week. Infection is one of the major risks. Increasingly, many infections do not respond to normal antibiotic treatment due to resistant bacteria which results in 7,000 amputations per year.

“There is an urgent need for innovation in wound management and treatment and it is a real privilege to be part of the international team who have been working on this alternative treatment for over 10 years.”

The cost of managing chronic wounds such as diabetic foot ulcers already exceeds $17 billion US dollars annually.

The benefits of cold plasma ionised gas have already been proven in clinical trials, showing it controls not only infection but also stimulates healing. This is due to the potent chemical cocktail of oxidants, namely reactive oxygen and nitrogen species (RONS) it produces when it mixes and activates the oxygen and nitrogen molecules in the ambient air.

Dr Endre Szili, from the University of South Australia who led the study, published this week in the journal Advanced Functional Materials, said: “Antibiotics and silver dressings are commonly used to treat chronic wounds, but both have drawbacks.

“Growing resistance to antibiotics is a global challenge and there are also major concerns over silver-induced toxicity. In Europe, silver dressings are being phased out for this reason.”

The international team of scientists have shown that plasma activating hydrogel dressings with RONS makes the gel far more powerful, killing common bacteria.

Although diabetic foot ulcers were the focus of this study, the technology could be applied to all chronic wounds and internal infections.

“Despite recent encouraging results in the use of plasma activated hydrogel therapy (PAHT), we faced the challenge of loading hydrogels with sufficient concentrations of RONS required for clinical use. We have overcome this hurdle by employing a new electrochemical method that enhances the hydrogel activation,” said Dr Szili.

As well as killing common bacteria (E. coli and P. aeruginosa) that cause wounds to become infected, the researchers say that the plasma activated hydrogels might also help trigger the body’s immune system, which can help fight infections.

“Chronic wound infections are a silent pandemic threatening to become a global healthcare crisis,” added Dr Szili.

“It is imperative that we find alternative treatments to antibiotics and silver dressings because when these treatments don’t work, amputations often occur.”

“A major advantage of our PAHT technology is that it can be used for treating all wounds. It is an environmentally safe treatment that uses the natural components in air and water to make its active ingredients, which degrade to non-toxic and biocompatible components.”

“The active ingredients could be delivered over a lengthy period, improving treatment, with a better chance of penetrating a tumour.

“Plasma has massive potential in the medical world, and this is just the tip of the iceberg,” Dr Szili says.

The next step will involve clinical trials to optimise the electrochemical technology for treatment in human patients.

Reference:

Sumyea Sabrin, Sung-Ha Hong, Sushil Kumar KC, Jun-Seok Oh, Ainslie L.K. Derrick-Roberts, Debabrata K. Karmokar, Habibullah Habibullah, Robert D. Short, Bhagirath Ghimire, Robert Fitridge, Endre J. Szili, Electrochemically Enhanced Antimicrobial Action of Plasma-Activated Poly(Vinyl Alcohol) Hydrogel Dressings, Advanced Functional Materials, https://doi.org/10.1002/adfm.202314345.

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Loneliness worse than smoking, alcoholism, obesity among elderly patients, suggests study

Loneliness is a significant biopsychosocial stressor with a mortality risk comparable to smoking more than 15 cigarettes a day and more harmful than alcoholism, obesity and lack of physical activity.

Despite its harmful effects, interventions to address the discrepancy between desired and actual social interaction are few and limited.

In a new study, Regenstrief Institute and Indiana University School of Medicine research scientists Monica Williams-Farrelly, PhD, Malaz Boustani, M.D., MPH, and Nicole Fowler, PhD, MHSA, identified evidence suggesting primary care clinicians can play an important role in developing and maintaining personal connections for patients experiencing loneliness.

The study found that 53 percent of older adults in the primary care population experience loneliness. Evidence also suggests that when older adults experience loneliness their physical and mental health related to quality of life are reduced significantly.

“The first and obvious answer for loneliness is for primary care physicians to screen their patients,” said Dr. Williams-Farrelly, the study’s first author, a Regenstrief research scientist and an assistant research professor at IU School of Medicine. “Based on the literature and research, loneliness has influences on health that are quite significant and quite strong, so in the same way that we ask older adults: Do you smoke? Or do you measure your blood sugar? We should be inquiring about and measuring loneliness and offering solutions.”

Dr. Williams-Farrelly suggests that it is imperative for primary care physicians, nurse practitioners and other clinicians also to provide resources to patients to help address this significant issue.

“The topic of loneliness is more relevant now than ever given the May 2023 U.S. Surgeon General’s call to action to tackle the loneliness epidemic,” said Dr. Fowler, principal researcher and senior author.

“This research is important because it identifies and suggests evidence for interventions that are necessary for older adults in primary care who experience loneliness. Primary care clinicians should discuss loneliness with their older adult patients and provide resources to help them create meaningful social relationships.” Dr. Fowler also is a Regenstrief research scientist and an associate professor and a director of research at IU School of Medicine.

An effective intervention, the researchers suggest, is the Circle of Friends concept, which consists of a three-month, group-based, psychosocial rehabilitation model aimed at enhancing interaction and friendships between participants. The model has shown effectiveness in both reducing loneliness and improving health outcomes including subjective health, cognition, mortality and lower healthcare costs.

“As older adults age, they have a lot of changes in their life due to a lot of circumstances – retirement, divorce or the death of family and friends – making it a little more difficult for them to maintain social relationships. When connections are lost with coworkers or loved ones, it can be jarring,” said Dr. Williams-Farrelly. “Older adults need their primary care physicians to screen and suggest effective resources that can allow them to maintain, foster and develop social relationships.”

Data was gathered during the COVID-19 pandemic, but the researchers identified a steadily increasing trend in loneliness in this population prior to the global pandemic. The numbers are still increasing today.

“Loneliness may seem simple, but it can be complex to identify and address. It started to become a problem before COVID-19, and then with the national stay-at-home order caused by the pandemic, social contact was being prevented, which exacerbated the problem,” said Dr. Williams-Farrelly.

Reference:

Monica M. Williams-Farrelly PhD, Matthew W. Schroeder MS, Claudia Li BS, Anthony J. Perkins MS, Tamilyn Bakas PhD, RN, Katharine J. Head PhD, Malaz Boustani MD, MPH, Nicole R. Fowler PhD, Loneliness in older primary care patients and its relationship to physical and mental health-related quality of life, Journal of the American Geriatrics Society, https://doi.org/10.1111/jgs.18762.

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Pancreatic enzyme replacement therapy may cut risk of acute Pancreatitis in kids with acute recurrent pancreatitis: Study

A recent study discovered that pancreatic enzyme replacement therapy (PERT) may significantly reduce the frequency of acute pancreatitis (AP) episodes in children who were diagnosed with acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) and still have sufficient pancreatic function. The findings of this study published in the American Journal of Gastroenterology offer new hope for managing the painful episodes and high hospitalization rates.

Acute pancreatitis represents a major challenge in pediatric gastroenterology due to its debilitating pain and potential to progress into chronic illness that necessitates frequent hospital interventions. Traditionally, no preventative treatments for AP episodes have been available by making the management of ARP and CP particularly difficult.

The study encompassed a total of 356 children who retained adequate pancreatic function with a significant majority, 270 participants suffered from ARP. Only 60 children received PERT as part of their treatment regimen. The study noted that after starting PERT, 42% of these children did not experience further AP episodes during the average follow-up period of 2.1 years.

The findings of this research unveils the effectiveness of PERT in reducing the annual incidence rate of AP episodes. Before initiating PERT, the mean annual rate of AP episodes stood at 3.14 per patient. This rate dramatically decreased to just 0.71 after the treatment by marking a significant improvement in managing the condition.

Genetic factors also played a role in the success of this therapy. The outcomes highlighted that children with a SPINK1 gene mutation and those who were diagnosed with ARP showed a reduced likelihood of experiencing AP episodes post-PERT initiation. This genetic insight points to a potential tailored approach in treating pancreatitis based on individual genetic profiles.

These results strongly support the initiation of a clinical trial to verify the efficacy of PERT in enhancing the clinical outcomes for children with these pancreatic conditions. The study advocates for such trials to answer the need of establishing concrete evidence to integrate PERT into standard treatment protocols. 

Reference:

Freeman, A. J., Ng, K., Wang, F., Abu-El-Haija, M. A., Chugh, A., Cress, G. A., Fishman, D. S., Gariepy, C. E., Giefer, M. J., Goday, P., Gonska, T. Y., Grover, A. S., Lindblad, D., Liu, Q. Y., Maqbool, A., Mark, J. A., McFerron, B. A., Mehta, M. S., … Morinville, V. D. (2024). Pancreatic Enzyme Use Reduces Pancreatitis Frequency in Children With Acute Recurrent or Chronic Pancreatitis: A Report From INSPPIRE. In American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.14309/ajg.0000000000002772

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Treating gum disease after heart rhythm ablation reduced risk of AFib recurrence: Study

Treating gum disease in the 3-months after a procedure to correct an irregular heartbeat known as atrial fibrillation (AFib) may lower oral inflammation and may reduce AFib recurrence, according to new research published today in the Journal of the American Heart Association, an open access, peer-reviewed journal of the American Heart Association.

According to the U.S. Centers for Disease Control and Prevention (CDC), about half of American adults ages 30 or older have some form of periodontal or gum disease, with the incidence increasing with age.

This study is among the first to investigate the potential impact of gum disease treatment on AFib. AFib is a condition in which the heart beats irregularly, increasing the risk of stroke by five-fold. More than 12 million people in the U.S. are expected to have AFib by 2030, according to the American Heart Association’s 2024 Heart Disease and Stroke Statistics.

“Gum disease can be modified by dental intervention. Proper management of gum disease appears to improve the prognosis of AFib, and many people around the world could benefit from it,” said lead study author Shunsuke Miyauchi, M.D., Ph.D., an assistant professor at the Health Service Center at Hiroshima University in Japan who engages in general cardiology, arrhythmia practice and research.

Researchers followed 97 patients who had undergone the non-surgical procedure to correct AFib (radiofrequency catheter ablation) and received treatment for gum inflammation along with 191 ablation patients who did not receive treatment for gum disease. Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue causing rapid and irregular heartbeats. This study found that an index measuring the severity of gum inflammation was associated with the return of AFib.

After the ablation procedure, during the average follow-up period of between 8.5 months to 2 years, researchers found:

AFib recurred among 24% of all participants throughout the follow-up period.

Patients with severe gum inflammation who had it treated after heart catheter ablation were 61% less likely to have a recurrence of AFib, compared to ablation patients who did not have treatment for severe gum inflammation.

Patients who had recurrences of AFib had more severe gum disease than those who did not have recurrences.

Having gum disease, being female, experiencing irregular heartbeat for more than two years and left atrial volume were predictors for AFib recurrences. Left atrial volume often leads to AFib recurrence as it includes thickening and scarring of connective tissues, Miyauchi explained.

Miyauchi noted that, “While the main findings were consistent with their expectations, we were surprised how useful a quantitative index of gum disease, known as periodontal inflamed surface area or PISA, could be in cardiovascular clinical practice.”

While the American Heart Association does not recognize oral health as a risk factor for heart disease, it recognizes that oral health can be an indicator of overall health and well-being. Bacteria from inflamed teeth and gums may travel through the bloodstream to the rest of the body, including the heart and brain. Chronic gum inflammation may be associated with other systemic health conditions, including coronary artery disease, stroke and Type 2 diabetes.

Study details and background:

A total of 288 adults (66% men; 34% women) being treated for AFib were enrolled in this study.

The single center study was conducted from April 1, 2020 to July 31, 2022, at Hiroshima University Hospital in Hiroshima, Japan, and all participants were Asian.

Enrollees were examined by a dentist before undergoing catheter ablation for AFib.

“We are now working on further research to reveal the mechanism underlying the relationship between gum disease and AFib,” Miyauchi said.

The study’s limitations include: a small number of patients enrolled from a single center; patients were not randomized to receive dental treatment; periodontal status was not followed up after the initial examination among the participants who did not receive gum disease treatment; and inflammatory markers were not reassessed after the ablation procedure.

References: Shunsuke Miyauchi, Kazuhisa Ouhara, Tomoaki Shintani, Takehito Tokuyama, Yousaku Okubo, Sho Okamura, Shogo Miyamoto, Naoto Oguri, Yukimi Uotani, Tasuku Takemura, Misako Tari, Toru Hiyama, Mutsumi Miyauchi, Mikihito Kajiya, Noriyoshi Mizuno and Yukiko Nakano Originally published10 Apr 2024https://doi.org/10.1161/JAHA.123.033740Journal of the American Heart Association. 2024;0:e033740

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Acquired hyperammonemia and carnitine deficiency mimicking urea cycle disorder: Case study

USA: A recent article describes a case of nutritionally driven acquired urea cycle disorder with carnitine deficiency leading to severe hyperammonemia, encephalopathy, and extensive MRI changes. All resolved completely with the correction of the underlying essential amino acid deficiency.

“It is important to find the etiology of underlying metabolic derangements and should accordingly treat and prognosticate,” the researchers wrote. The findings were presented at the American Academy of Neurology (AAN) annual meeting in 2024.

Hyperammonemia is caused mostly by defects or overproduction in detoxification due to liver disorders. Rare causes of hyperammonemia include fatty acid oxidation disorder, urea cycle disorder, Reye syndrome, organic acidemias, and valproic acid toxicity. Ammonia is neurotoxic and can lead to cerebral edema.

Urea cycle disorders are a group of rare genetic conditions characterized by deficiencies in enzymes responsible for detoxifying ammonia in the body. These disorders often present with symptoms such as lethargy, vomiting, seizures, and hyperammonemia, posing significant challenges in diagnosis and management.

Michelle DeJesus Brazitis and Beenish Javaid from the USA report a case of a middle-aged woman with chronic alcohol-related necrotizing pancreatitis presenting with myoclonic status epilepticus with MRI brain indicating extensive symmetric T2 hyperintensity and diffusion restriction throughout the bilateral cerebral cortex with relative sparing of white matter, brainstem, deep gray nuclei, and cerebellum.

Workup revealed resistant (defiant to medical therapy and CRRT) and severe (265 u mol/L) hyperammonemia despite lack of cirrhosis, portal venous congestion, or inciting medications.

The study led to the following findings:

· Metabolic-genetic workup revealed a metabolic pattern– elevated urine orotic acid and glutamine with low total and free citrulline level– consistent with proximal urea cycle defect likely OTC- Ornithine transcarboxylase deficiency or CPS1- Carbamoyl phosphate synthetase 1 deficiency.

· The next-generation sequencing test was negative for any genetic cause (Urea cycle enzymes or transporters) of hyperammonemia. Thus, chronic pancreatitis leading to exocrine pancreatic insufficiency, protein, and micronutrient malnutrition was considered to be the etiology of acquired/secondary urea cycle dysfunction leading to hyperammonemia.

· IV Scavenger therapy with Arginine, L Carnitine, and ammonul- a combination of sodium benzoate and sodium phenylacetate contributed to the resolution of hyperammonemia, encephalopathy, and MRI changes.

In conclusion, recognizing acquired hyperammonemia secondary to L-carnitine deficiency as a potential mimic of urea cycle disorders is paramount for optimizing patient care and preventing unnecessary interventions.

“Further research is warranted to elucidate the underlying mechanisms and identify effective therapeutic strategies for this rare metabolic condition,” the researchers wrote.

“It is important to find the etiology of underlying metabolic derangements and should accordingly treat and prognosticate,” they concluded. 

Reference:

10.1212/WNL.0000000000204946

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Metagenomic next-generation sequencing improves diagnosis of intra abdominal infections in sepsis patients: Study

Researchers have found that metagenomic next-generation sequencing (mNGS) of paired plasma and peritoneal drainage (PD) fluid samples offers superior diagnostic and therapeutic utility in the management of septic patients with suspected acute intra-abdominal infections (IAIs). This novel approach has shown promise in optimizing empirical antibiotic use and improving patient outcomes. This study was published in BMC Infectious Diseases. The study was conducted by Jia-Yu Mao and colleagues.

Acute intra-abdominal infections are a significant cause of morbidity and mortality in critically ill patients. Accurate diagnosis and effective treatment are essential to improve patient outcomes. Culture-based microbiological tests (CMTs) have been the standard method for detecting pathogens, but they have limitations. Metagenomic next-generation sequencing (mNGS) has been increasingly applied in sepsis and offers a comprehensive approach to pathogen detection.

In a prospective study conducted from October 2021 to December 2022, 111 septic patients with suspected IAIs were enrolled. Pairwise CMTs and mNGS of plasma and PD fluid samples were performed to detect pathogens. The mNGS group underwent therapeutic regimen adjustment based on mNGS results for improved treatment. Researchers analyzed the microbial community structure, clinical features, antibiotic use, and prognoses of the patients.

The key findings of the study were:

  • mNGS demonstrated higher positivity rates than CMTs for both PD fluid (90.0% vs. 48.3%, p < 0.005) and plasma (76.7% vs. 1.6%, p < 0.005).

  • The combination of mNGS and CMT methods provided clues of suspected pathogens in 90% of enrolled patients.

  • Gram-negative pathogens, including a great variety of anaerobes represented by Bacteroides and Clostridium, comprised most intra-abdominal pathogens.

  • Patients with matched plasma and PD mNGS results exhibited higher mortality and sepsis severity.

  • Reduced usage of carbapenem (30.0% vs. 49.4%, p < 0.05) and duration of anti-MRSA treatment (5.1 ± 3.3 vs. 7.0 ± 8.4 days, p < 0.05) were observed in the mNGS group.

The study suggests that pairwise plasma and PD fluid mNGS offers improved microbiological diagnosis compared to CMTs for acute IAI. The high positivity rates observed with mNGS indicate its potential as a valuable diagnostic tool. The matched plasma and PD mNGS results may predict poor prognosis, suggesting the need for more aggressive management.

Combining plasma and PD mNGS can enhance microbiological diagnosis and predict poor prognosis in patients with acute IAIs. mNGS may enable optimized empirical antibiotic use, reducing the use of broad-spectrum antibiotics and enhancing targeted therapy.

Reference:

Mao, J.-Y., Li, D.-K., Zhang, D., Yang, Q.-W., Long, Y., & Cui, N. (2024). Utility of paired plasma and drainage fluid mNGS in diagnosing acute intra-abdominal infections with sepsis. BMC Infectious Diseases, 24(1). https://doi.org/10.1186/s12879-024-09320-1

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Zydus Gets CDSCO Panel Nod To Manufacture Market Letermovir 240 mg, 480 mg Tablet

New Delhi: The drug major Zydus has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Letermovir 240 mg and 480 mg tablets with Phase-III clinical trial waiver.

However, this nod is subject to the condition that Zydus should submit the Phase-IV clinical trial (CT) protocol to CDSCO within three months of the grant of permission.

Furthermore, the expert panel suggested that the drug product be sold on the prescription of specialists in organ transplant, infectious disease, hematologist, etc.

This came after Zydus presented the proposal for a grant of permission to manufacture and market Letermovir tablets 240mg and 480 mg with a Phase-III clinical trial waiver request, along with a bioequivalence (BE) study report.

Letermovir is an antiviral medication used for prophylaxis in adult transplant recipients at risk of cytomegalovirus (CMV) infection and disease.

Letermovir is indicated for prophylaxis against cytomegalovirus (CMV) infection and disease in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT) who are CMV-seropositive. It is also indicated for prophylaxis against CMV disease in adult kidney transplant recipients who are at risk (i.e. donor CMV-seropositive/recipient CMV-seronegative).

Letermovir is a viral terminase inhibitor. It specifically inhibits the CMV viral terminase complex which is encoded by the CMV genes UL56, UL51, and UL89. This inhibition has the effect of preventing cleavage of CMV DNA concatamers, resulting in long-uncleaved DNA and noninfectious viral particles.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal presented by the drug major Zydus for the approval to manufacture and market the drug Letermovir.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Letermovir tablets 240mg and 480 mg in the country with the following conditions:

i) The firm shall submit Phase-IV CT protocol to CDSCO within three months of grant of permission.

ii) The drug product to be sold on prescription of specialists in organ transplant, infectious disease, hematologist, etc.

Also Read: Novartis Gets CDSCO Panel Nod to Study anti-cancer drug Ribociclib

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Invoke steps under health act: Kerala minister directs officials on bird flu outbreak

The recent outbreak of bird flu in two wards of Alappuzha has prompted Health Minister Veena George to take swift action under the Kerala Public Health Act, 2023. She has instructed the director of the health department to initiate necessary measures to contain the spread of the virus.

Panchayat-level committees are being urgently convened in all panchayats of Alappuzha to address the situation effectively. Additionally, neighboring areas are under close surveillance, with district-level monitoring in place. Progress reports are mandated to be submitted at the state level to ensure coordinated efforts.

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