Multicentric validation of the PathoDetect™ MTB RIF & INH assay for simultaneous detection of Mycobacterium tuberculosis, & drug resistance to rifampicin & isoniazid in presumptive pulmonary tuberculosis & drug-resistant TB patients.

Background & objectives Tuberculosis (TB) remains a major global health concern, with India accounting for 26 per cent of the global burden. Despite advances, access to rapid molecular diagnostics is limited, and the assays currently used in National TB Elimination Programme (NTEP) do not detect isoniazid (INH) resistance upfront. PathoDetect™ MTB RIF & INH is an indigenous closed-system assay that simultaneously detects Mycobacterium tuberculosis (MTB) and resistance to rifampicin (RIF) and INH.

Energy dense nutritional supplements improve weight gain among malnourished adults with drug-sensitive pulmonary tuberculosis: an open-label randomized controlled trial in Faridabad, India.

This open-label randomized controlled trial in India assessed the impact of a peanut-based energy-dense nutritional supplement (EDNS) on weight gain among undernourished adults with drug-susceptible pulmonary tuberculosis in India. EDNS significantly improved weight gain compared to standard care, offering a scalable solution for targeted nutritional support.

Operational Feasibility of "TB Concentration & Transport" and "TB DNA Extraction" Kits for Biosafe Dry Sputum Transport for Direct Detection of Drug Resistance Using Line Probe Assay: A Field Study in India.

Background: We recently described the utility of the "TB Concentration & Transport" kit for biosafe, ambient temperature transport of dried sputum on -Filter, and the "TB DNA Extraction" kit for DNA extraction from -Filter for the early diagnosis of drug-resistant tuberculosis (TB). This study aimed to assess the feasibility and compatibility of these kits with line probe assay (LPA) under National Tuberculosis Elimination Programme (NTEP) settings.

Methods: Patients with presumptive pulmonary TB, multidrug-resistant (MDR) TB, or extensively drug-resistant TB (N = 8491) who attended Designated Microscopy Centers (DMCs, n = 13) under National Reference Laboratories (NRLs) at Bhopal, New Delhi, Chennai, and Bhubaneswar were screened by smear microscopy.

Four-month clofazimine regimen for susceptible pulmonary TB: a randomized clinical trial.

Background: Clofazimine, an antimycobacterial agent, has demonstrated efficacy in reducing the treatment duration for MDR TB.

Objectives: To determine whether a 16 week clofazimine-based regimen is non-inferior to the standard 24 week regimen for drug-susceptible pulmonary TB.

Methods: CORTAIL was a multicentric, investigator-initiated, randomized controlled trial designed to assess the non-inferiority of a 16 week clofazimine-based regimen compared with the standard 24 week regimen for drug-susceptible pulmonary TB (Clinical Trials Registry of India no.

A Situational Analysis and an Untapped Opportunity for Tackling Challenges Associated with Coverage of Tuberculosis Preventive Treatment: A Multi-Centric Study in India.

Objectives: To assesses the coverage, adherence, reasons for non-initiation and non-completion of tuberculosis preventive treatment (TPT) among household child contacts (HHCC) of pulmonary tuberculosis (TB).

Methods: This cross-sectional study was conducted across eight sites in India. Estimated sample size was 200 per site.

Operational feasibility and multi-centric evaluation of 'TB sputum microscopy kit' for the direct detection of in field settings.

Background: India relies primarily on direct smear microscopy for tuberculosis (TB) diagnosis. However, the low sensitivity of smear microscopy emphasizes the need to improve its performance. We recently described the development of 'TB' kit which showed improved performance over direct smear microscopy at National Reference Laboratories (NRLs) in India.

Multi-centric evaluation of Truenat MTB and MTB-RIF Dx assays for diagnosis of extrapulmonary tuberculosis.

Extra-pulmonary TB (EPTB) is difficult to diagnose due to paucibacillary nature of disease. Current study evaluated accuracy of Truenat MTB and MTB-Rif Dx (TN), for detection of Mycobacterium tuberculosis and resistance to rifampicin. Samples were collected from 2103 treatment naive adults with presumptive EPTB, and tested by smear microscopy, liquid culture (LC) (MGIT-960) and GeneXpert MTB/RIF (GX) (Microbiological Reference Standards, MRS).

Effect of Metformin on systemic chemokine responses during anti-tuberculosis chemotherapy.

Background: Metformin (MET), by boosting immunity, has been suggested as a host-adjunctive therapy to anti-tuberculosis treatment (ATT).

Methods: We evaluated whether adding MET to the standard ATT can alter the host chemokine response. We investigated the influence of metformin on the plasma levels of a wide panel of chemokines in a group of active tuberculosis patients before treatment, at 2nd month of ATT and at 6-months of ATT as part of our clinical study to examine the effect of metformin on ATT.

Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial.

Background: Globally, no trial data are available on head-to-head comparison between 10 mg/kg and 25/35 mg/kg rifampicin in treating pulmonary tuberculosis during study initiation.

Methods: A multicentric, phase IIb randomized trial recruited 333 new culture-positive, drug-sensitive adult patients with pulmonary tuberculosis to compare safety and efficacy of high-dose rifampicin (R25/R35), against conventional dose (R10) given daily for 8 weeks followed by standard doses for 16 weeks. Main outcomes were treatment-emergent grade 3/4 adverse events (AEs) and time-to-culture conversion in liquid media, assessed by division of AIDS system for grading the severity of adverse events division of AIDS criteria and Kaplan-Meier methods.

Developing Standard Treatment Workflows-way to universal healthcare in India.

Primary healthcare caters to nearly 70% of the population in India and provides treatment for approximately 80-90% of common conditions. To achieve universal health coverage (UHC), the Indian healthcare system is gearing up by initiating several schemes such as National Health Protection Scheme, Ayushman Bharat, Nutrition Supplementation Schemes, and Inderdhanush Schemes. The healthcare delivery system is facing challenges such as irrational use of medicines, over- and under-diagnosis, high out-of-pocket expenditure, lack of targeted attention to preventive and promotive health services, and poor referral mechanisms.

Pulmonary Tuberculosis in Severely Malnourished Children Admitted to Nutrition Rehabilitation Centers: A Multicenter Study.

Objectives: To identify prevalence of pulmonary tuberculosis (TB) in severely malnourished children admitted to nutritional rehabilitation centers.

Methods: A multicenter cross-sectional study involving 41 nutrition rehabilitation centres (NRCs) across India was carried out to document prevalence of pulmonary tuberculosis in acute severe malnourished children admitted in NRCs. After training of the NRC staff to follow algorithm provided by national tuberculosis elimination program, children admitted to NRCs were screened for pulmonary tuberculosis.

A comparison of the quality of images of chest X-ray between handheld portable digital X-ray & routinely used digital X-ray machine.

Background & Objectives: Chest X-ray (CXR) is an important screening tool for pulmonary tuberculosis (TB). Accessibility to CXR facilities in difficult-to-reach and underserved populations is a challenge. This can potentially be overcome by deploying digital X-ray machines that are portable.

Expedited diagnosis of pediatric tuberculosis using Truenat MTB-Rif Dx and GeneXpert MTB/RIF.

Rapid, cost-effective, and sensitive diagnostic assays are essential for global tuberculosis (TB) control, especially in high TB burden, resource-limited settings. The current study was designed to evaluate diagnostic accuracy of Truenat MTB-Rif Dx (MolBio) in children less than 18 years of age, with symptoms suggestive of TB. Gastric aspirate, induced sputum, and broncho-alveolar lavage samples were subjected simultaneously to AFB-smear, GeneXpert MTB/RIF, liquid culture (MGIT-960) and Truenat MTB-Rif Dx.

In-vivo studies on Transitmycin, a potent Mycobacterium tuberculosis inhibitor.

This study involves the in-vitro and in-vivo anti-TB potency and in-vivo safety of Transitmycin (TR) (PubChem CID:90659753)- identified to be a novel secondary metabolite derived from Streptomyces sp (R2). TR was tested in-vitro against drug resistant TB clinical isolates (n = 49). 94% of DR-TB strains (n = 49) were inhibited by TR at 10μg ml-1.

High-Dose Rifampicin Mediated Systemic Alterations of Cytokines, Chemokines, Growth Factors, Microbial Translocation Markers, and Acute-Phase Proteins in Pulmonary Tuberculosis.

High-dose rifampicin (HDR) is now undergoing clinical trials to improve the efficacy of anti-tuberculosis treatment (ATT). However, the influence of HDR in the modulation of different cytokines, chemokines/growth factors, microbial translocation markers (MTMs), and acute-phase proteins (APPs) in pulmonary tuberculosis (PTB) is not well known. PTB individuals were separated into three different arms (R10, R25, and R35) based on their rifampicin dosage.

Assessment of prevailing practices for identification of tuberculosis in children admitted in nutritional rehabilitation centres: A multicentre study.

Background & Objectives: To eliminate tuberculosis (TB), the National TB Elimination Programme (NTEP) has given an algorithm for diagnosis and treatment of TB in children. This study was carried out to assess the prevailing practices to identify TB in severely malnourished children admitted to various nutrition rehabilitation centres (NRCs).

Methods: A retrospective chart review of 41 NRCs across five States having a maximum number of NRCs was carried out.

Single ascending dose safety, tolerability, and pharmacokinetic study of econazole in healthy volunteers.

Introduction: Econazole has been found efficacious as antitubercular in in vitro and in vivo animal studies. However, limited information is available for its safety and pharmacokinetics in humans. In our present study we have conducted single ascending dose, safety, and pharmacokinetic evaluation in healthy human volunteers with the purpose of enabling translation for tuberculosis.

Effectiveness of community-based treatment programs for treatment of uncomplicated severe acute malnourished children aged 6-59 months using locally produced nutrient dense foods: protocol for a multicentric longitudinal quasi-experimental study.

Background: Severe acute malnutrition (SAM) is a major underlying cause of mortality among children. Around one third of the world's acutely malnourished children live in India. The WHO recommends community-based management of acute malnutrition (CMAM) for managing children with SAM.

Randomized Trial of Metformin With Anti-Tuberculosis Drugs for Early Sputum Conversion in Adults With Pulmonary Tuberculosis.

Background: Metformin, by reducing intracellular Mycobacterium tuberculosis growth, can be considered an adjunctive therapy to anti-tuberculosis treatment (ATT). We determined whether metformin with standard ATT reduces time to sputum culture conversion and tissue inflammation in adults with pulmonary tuberculosis (PTB).

Methods: In a randomized, 8-week, clinical trial, newly diagnosed, culture-positive PTB patients were randomized to standard ATT (HREZ = control arm) or standard ATT plus daily 1000 mg metformin (MET-HREZ = Metformin with Rifampicin [METRIF] arm) for 8 weeks during 2018-2020 at 5 sites in India.

Cost-effectiveness of incorporating vaccine to multidrug therapy in newly diagnosed leprosy cases for better treatment outcomes & immunoprophylaxis in contacts as leprosy control measures for National Leprosy Eradication Programme in India.

Background & Objectives: The elimination goal for leprosy as a public health problem at the national level was achieved in 2005 in India. However, the number of new cases reporting annually remained nearly the same during the last 10-15 years. Moreover, a substantial number of these new cases reported disabilities for the first time.

RAPIDIRON: Reducing Anaemia in Pregnancy in India-a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries.

Background: Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes. India's anaemia rate is among the highest in the world with India's National Family Health Survey indicating over 50% of pregnant women were affected by anaemia.

Compatibility of a novel filter paper-based bio-safe sputum transport kit with line probe assay for diagnosing drug-resistant tuberculosis: a single-site evaluation study.

Background: Near-patient access to appropriate tests is a major obstacle for the efficient diagnosis of tuberculosis (TB) and associated drug resistance.

Methods: We recently developed the "TB Concentration & Transport" kit for bio-safe, ambient-temperature transportation of dried sputum on -Filter, and the "TB DNA Extraction" kit for DNA extraction from -Filter for determining drug resistance by DNA sequencing. In the present study, we evaluated the compatibility of Kit-extracted DNA with Hain's line probe assays (LPAs), which are endorsed by National TB programmes for the detection of drug resistance in sputum collected from presumptive multidrug-resistant TB patients (=207).