Tuberculosis

HIV, Gestational Diabetes and TB in Pregnancy (PraGaTHi)

Post Date: 
2023-02-27
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
The purpose of this study is to learn about how diabetes, TB, and HIV affect pregnant women and whether pregnancy, HIV and diabetes increase the risk of acquiring TB during pregnancy and postpartum. During pregnancy, some women will develop a form of diabetes (high blood sugar) called gestational...

1 to 3 HP

Post Date: 
2023-01-24
   |   
Countries: 
India
Indonesia
South Africa
Protocol Title: A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) to Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The “One...

A multicenter Phase II/ III double-blind, randomized, placebo controlled study to evaluate the efficacy and safety of VPM1002 in the prevention of tuberculosis (TB) recurrence in pulmonary TB patients after successful TB treatment in India.

Post Date: 
2022-05-08
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
To evaluate the efficacy of VPM1002 in prevention of TB recurrence in former pulmonary TB patients who have successfully completed ATT and were declared cured. Secondary Objective To evaluate the safety of VPM1002 in former TB patients who have successfully completed ATT and were declared as cured...

The Regional Prospective Observational Research In Tuberculosis (Report) India Phase II Common Protocol

Post Date: 
2022-01-10
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Countries: 
India
   |   
Clinical Sites: 
BJGMC
Hinduja Hospital
NIRT
Purpose and Scientific Aims The purpose of the RePORT India Phase II Common Protocol is to collect and utilize data and specimens for tuberculosis (TB) research, leveraging the existing infrastructure, processes, and scientific partnerships established under RePORT India consortium. The RePORT...

Innovative modelling for predicting TB treatment outcomes in global cohorts

Post Date: 
2021-12-19
Our overarching hypothesis is that clinical and laboratory risk factors for the adversity be treatment outcomes of failure, recurrence and mortality are heterogeneous and time-dependent. Precision medicine approaches supported by Machine learning techniques that overcome the limitations of...

Creating a Hope: A Mixed-Method Approach to Identify Most Acceptable Evidence-Based Psycho-Social Intervention to Improve the Retention in Care among Indian Youth Diagnosed with Multi-Drug Resistant TB (MDR-TB)

Post Date: 
2021-11-02
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
PURPOSE: Adolescents and youths with MDR/RR tuberculosis reported social isolation, stigmatization, depression, and poor self-esteem highlighting the importance of psychosocial support during tuberculosis treatment phase. Addressing the psycho-social need of youths, by identifying youth friendly...

“Bridging the Gaps”: Understanding the Barriers and Facilitators in the Tuberculosis Prevention Care Cascade for Optimizing Isoniazid Preventive Therapy Uptake among Adults Living with HIV in India, a Mixed-Method Approach

Post Date: 
2021-11-02
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
PURPOSE: The isoniazid preventive therapy policy has achieved limited success in low and middle-income countries. With limited empirical research exploring the barriers to suboptimal IPT uptake, it is important to understand this knowledge gap. Also, limited programmatic strategies exist to address...

Childhood ‘Omics’ and Mycobacterium tuberculosis-derived BiOsignatures (COMBO) for TB diagnosis

Post Date: 
2021-10-18
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Countries: 
India
   |   
Clinical Sites: 
BJGMC
The overall objective of the project is to identify Mtb- and/or host-derived biosignatures in children that can achieve World Health Organization (WHO) target product profile (TPP) accuracy thresholds for a non-sputum biomarker-based triage or diagnostic test for childhood TB. We hypothesize that...

Epidemiologic Factors Associated with TB Treatment Outcomes Across Report International Consortia

Post Date: 
2021-08-12
   |   
Countries: 
Brazil
China
India
Indonesia
Philippines
South Africa
Rationale: RePORT International was designed to enable cross-consortium data analysis. Now that a large number of consortium sites have completed participant enrollment in Common Protocol Cohort A, we can proceed with large-scale analysis of aligned RePORT data. The current study will harmonize and...

Biomarkers of Hepatotoxicity in Pregnant and Postpartum Women Living With HIV and Latent TB

Post Date: 
2021-06-21
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Countries: 
India
   |   
Clinical Sites: 
BJGMC
Primary objectives: 1. Quantify INH metabolite PK in pregnant and postpartum WLWH receiving IPT, and compare INH metabolites exposures between cases and controls. 1. Identify biomarkers of hepatotoxicity in pregnant and postpartum WLWH receiving IPT. 2. Model relationships between drug metabolite...

A5362: A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Post Date: 
2021-06-15
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Primary Hypothesis A 3-month regimen of rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) with clofazimine (CFZ) dosed as 100 mg daily with a 2-week 300 mg daily loading dose (Arm 1) will demonstrate early efficacy (time to 12-week liquid culture conversion) relative to standard of care (SOC) (...

The Pharmacokinetics, Safety and Acceptability of New Child-Friendly Formulations of Clofazimine and Moxifloxacin in Children Routinely Treated for Rifampicin-Resistant Tuberculosis (CATALYST)

Post Date: 
2021-04-26
   |   
Countries: 
India
Philippines
South Africa
   |   
Clinical Sites: 
BJGMC
PK, safety and acceptability data and practical guidance on the optimal dosing of new more child-friendly formulations of moxifloxacin and clofazimine in children are urgently needed to inform their current and future use in children with Rifampicin-Resistant TB (RR-TB). Both medications have a key...

Dynamics and immune mechanisms of QFT response in close contacts of TB cases

Post Date: 
2021-04-05
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Rationale: A vaccine that prevents infection with Mycobacterium tuberculosis (Mtb) (POI vaccine) is an ideal approach to TB control. As Mtb infection (MTBI) is measured indirectly (positive tuberculin skin test (TST) or interferon gamma release assay (IGRA), prevention of IGRA conversion is the...

A Nanopore Biosensor for Leveling MTB Antigens in Blood

Post Date: 
2021-04-01
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Purpose of the study: The inability to obtain diagnostically useful sputum specimens, or the inability to analyze non-sputum specimens, is a significant contributor to poor diagnostic sensitivity of current TB assays, leading to the WHO to call for the development of non-sputum-based biomarker or...

Pharmacokinetic Assessment of MDR-TB Drugs in the Treatment of TB Meningitis

Post Date: 
2020-08-23
   |   
Countries: 
China
India
South Africa
   |   
Clinical Sites: 
Hinduja Hospital
Rationale: MDR-TBM is a devastating disease with high mortality and severe neurologic sequelae among survivors. We recognize the importance of sufficient drug concentrations at the site of infection for efficacy of anti-TB drugs and believe it is likely that drug distribution into brain and CSF...

Identification of Biomarkers That Can Predict Progression from Latent Tuberculosis Infection to Active Tuberculosis Disease

Post Date: 
2020-08-23
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Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
Purpose: The C-TRIUMPH study has identified 20 household contacts (HHC), who have progressed to active TB from its HHCs cohort (Cohort B). Immunological profiling of TB antigen induced biosignatures, profiling of transcriptional and proteomic biosignatures should provide novel insights into the...

Tuberculosis (TB) Aftermath

Post Date: 
2020-06-05
   |   
Countries: 
India
   |   
Clinical Sites: 
DY Patil
Drs. Vidya Mave and Jonathan Golub are co-PIs and Dr. Barthwal from DY Patil Medical College is local site PI for this study. TB Aftermath seeks to provide evidence for an effective and scalable strategy targeting HHs of treated TB cases, a high priority of the NTEP. Purpose To compare the...

Hybrid Trial for Alcohol Reduction among People with TB and HIV in India

Post Date: 
2020-02-12
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
DY Patil
Dr. Geetanjali Chander is PI and Dr. Kakrani is local site PI at DY Patil Medical College for this study. The highest incidence of tuberculosis disease (TB) in the world is in India, accounting for 27% of all new cases globally, with approximately 86,000 among persons with HIV (PWH). Unhealthy...

Pregnancy Associated Immune Responses to Tuberculosis and HIV in India and South Africa (PARTHISA)

Post Date: 
2020-01-14
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Countries: 
India
South Africa
   |   
Clinical Sites: 
BJGMC
Dr. Jyoti Mathad is Co-PI of this study. Purpose: Tuberculosis (TB) is a leading cause of maternal mortality, especially among HIV-infected women. Women are most likely to develop active TB during and immediately after pregnancy. The immunologic conditions responsible for this phenomenon are not...

Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy for TB (IMPAACT4TB)

Post Date: 
2019-12-17
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Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
Primary Objective: This study is being conducted in Brazil, Cambodia, China, Ethiopia, Ghana, Haiti, India, Indonesia, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. The overall goal is to reduce TB incidence among (1) people living with HIV who are on antiretroviral therapy, and...

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Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial

Post Date: 
2023-09-13
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Countries: 
India
Publication: 
Lancet Child Adolescent Health
Deferral of maternal isoniazid preventive therapy to early postpartum had no effect on infant tuberculosis acquisition in our trial population, regardless of the diagnostic test used.

Mycobacterium tuberculosis disease associates with higher HIV-1-specific antibody responses

Post Date: 
2023-05-19
   |   
Countries: 
India
Publication: 
Science Direct
Mycobacterium tuberculosis (Mtb) is the most common infection among people with HIV (PWH). Mtb disease-associated inflammation could affect HIV-directed immune responses in PWH. We show that HIV antibodies are broader and more potent in PWH in the presence as compared to the absence of Mtb disease...

Operational challenges undermine the WHO TB symptom screen in pregnant women in India

Post Date: 
2023-04-26
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
Open Forum Infectious Diseases
Background. Pregnancy increases both a woman's risk of developing tuberculosis (TB) and her likelihood to seek health care. A symptom screen that is effective during pregnancy would therefore be valuable. We assessed a World Health Organization (WHO)-recommended TB symptom screen in an antenatal...

Impact of undernutrition on tuberculosis treatment outcomes in India: A multicenter prospective cohort analysis by Dr. Pranay Sinha

Post Date: 
2023-04-17
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Countries: 
India
   |   
Clinical Sites: 
BJGMC
NIRT
Publication: 
Clinical Infectious Diseases
Abstract Background Undernutrition is the leading risk factor for tuberculosis (TB) globally. Its impact on treatment outcomes is poorly defined. Methods We conducted a prospective cohort analysis of adults with drug-sensitive pulmonary TB at 5 sites from 2015–2019. Using multivariable Poisson...

Sex Differences in TB Clinical Presentation, Drug Exposure, and Treatment Outcomes in India

Post Date: 
2023-04-01
   |   
Countries: 
India
Publication: 
CHEST
Background: The role of sex differences in clinical presentation, TB drug pharmacokinetic variables, and treatment outcomes is unclear. Research question: What is the effect of sex on TB disease severity, drug exposure, and treatment outcome? Study design and methods: This study was a prospective...

Factors associated with prevalent Mycobacterium tuberculosis infection and disease among adolescents and adults exposed to rifampin-resistant tuberculosis in the household

Post Date: 
2023-03-17
   |   
Countries: 
India
Publication: 
PLOS ONE
Background: Understanding factors associated with prevalent Mycobacterium tuberculosis infection and prevalent TB disease in household contacts of patients with drug-resistant tuberculosis (TB) may be useful for TB program staff conducting contact investigations. Methods: Using data from a cross-...

Characterising cause of death among people treated for drug-susceptible TB in India

Post Date: 
2023-01-12
   |   
Countries: 
India
Publication: 
The International Journal of Tuberculosis and Lung Disease
Annually, 1.5 million people die of TB.1 India has thehighest burden of TB,1 and in 2020, the case fatality ratio (CFR) among people with drug-susceptible TB was 4.3%.2 Even after treatment, mortality is more than two-fold higher among people with prior TB compared to the general population.3...

Predictive performance of interferon-gamma release assays and the tuberculin skin test for incident tuberculosis: an individual participant data meta-analysis

Post Date: 
2023-01-05
   |   
Countries: 
India
Publication: 
EClinicalMedicine
Background: Evidence on the comparative performance of purified protein derivative tuberculin skin tests (TST) and interferon-gamma release assays (IGRA) for predicting incident active tuberculosis (TB) remains conflicting. We conducted an individual participant data meta-analysis to directly...

Pharmacokinetic analysis of linezolid for multidrug resistant tuberculosis at a tertiary care centre in Mumbai, India

Post Date: 
2023-01-04
   |   
Countries: 
India
Publication: 
Frontiers in Pharmacology
Linezolid is an oxazolidinone used to treat multidrug-resistant tuberculosis (MDR-TB), including in the recently-endorsed shorter 6-month treatment regimens. Due to its narrow therapeutic index, linezolid is often either dose-adjusted or discontinued due to intolerance or toxicity during treatment...

The Kynurenine / Tryptophan Ratio is a Sensitive Biomarker for the Diagnosis of Pediatric Tuberculosis among Indian Children

Post Date: 
2022-12-22
   |   
Countries: 
India
Publication: 
Frontiers in Immunology
Objectives: Pediatric tuberculosis (TB) remains difficult to diagnose. The plasma kynurenine to tryptophan ratio (K/T ratio) is a potential biomarker for TB diagnosis and treatment response but has not been assessed in children. Methods: We performed a targeted diagnostic accuracy analysis of four...

Metabolites enhance innate resistance to human Mycobacterium tuberculosis infection

Post Date: 
2022-11-22
   |   
Countries: 
India
Publication: 
JCI Insight
To determine the mechanisms that mediate resistance to Mycobacterium tuberculosis (M. tuberculosis) infection in household contacts (HHCs) of patients with tuberculosis (TB), we followed 452 latent TB infection-negative (LTBI-) HHCs for 2 years. Those who remained LTBI- throughout the study were...

Developing TB Vaccines for People with HIV: A Roadmap: Meeting Consensus Report

Post Date: 
2022-11-09
Publication: 
Lancet HIV
New tuberculosis vaccine candidates that are in the development pipeline need to be studied in people with HIV, who are at high risk of acquiring Mycobacterium tuberculosis infection and tuberculosis disease and tend to develop less robust vaccine-induced immune responses. To address the gaps in...

Impact of pregnancy and HIV on LTBI diagnostics and MTB-induced immune response: a cohort study in Pune, India

Post Date: 
2022-11-01
   |   
Countries: 
India
Publication: 
International Journal of Infectious Diseases
Background Accurate tuberculosis infection (TBI) tests are critical for pregnant women, especially those with HIV, who have a high risk of TB disease. Methods We enrolled interferon gamma release assay (IGRA)+ pregnant women with and without HIV in a longitudinal study, followed up at delivery and...

Willingness of Caregivers to Give Preventive Therapy to Children Living in Households of Patients with Rifampin-resistant Tuberculosis

Post Date: 
2022-10-26
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
The International Journal of Tuberculosis and Lung Disease
BACKGROUND Pediatric household contacts (HHCs) of patients with multidrug-resistant TB (MDR-TB) are at high risk of infection and active disease. Evidence of caregiver willingness to give MDR-TB preventive therapy (TPT) to children is limited. METHODS This was a cross-sectional study of HHCs of...

Whole Genome Sequencing Assessing Impact of Diabetes Mellitus on Tuberculosis Mutations and Type of Recurrence in India

Post Date: 
2022-10-06
   |   
Countries: 
India
Publication: 
Clinical Infectious Diseases
Dr. Vidya Mave and colleagues concluded considerable intrahost mycobacterium tuberculosis mutation rates were present at recurrence among patients with diabetes mellitus.

Population Pharmacokinetic Modeling and Simulation of Rifapentine Allow Concomitant Antiretroviral Therapy with Efavirenz and Non-Weight Based Dosing

Post Date: 
2022-09-20
   |   
Countries: 
India
Publication: 
Antimicrobial Agents and Chemotherapy
ABSTRACT The Brief Rifapentine–Isoniazid Efficacy for TB Prevention/A5279 trial demonstrated a 1-month daily regimen of rifapentine and isoniazid was noninferior to 9 months of isoniazid alone for preventing TB in persons living with HIV (PLWH). Our objective was to evaluate rifapentine...

Accuracy of Xpert MTB/RIF Ultra for the diagnosis of tuberculosis in adult patients: a retrospective cohort study

Post Date: 
2022-09-01
   |   
Countries: 
India
Publication: 
International Journal of Infectious Diseases
Abstract Objectives: The value of the "trace" result in Xpert Ultra for diagnosing active tuberculosis (TB) remains unclear. Our study evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Xpert Ultra) (Cepheid, Sunnyvale, USA) over Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, USA) and...

Concomitant pulmonary disease is common among patients with extrapulmonary TB

Post Date: 
2022-08-12
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
International Journal of Tuberculosis and Lung Disease
Dr. Shivakumar and his group discovered that a high proportion of patients classified as EPTB in India have concomitant PTB. Their results support the need for improved symptom and CXR screening, and recommends routine sputum TB microbiology screening of all Indian patients with EPTB.

Pregnancy in Women with HIV in a Tuberculosis Preventive Therapy Trial

Post Date: 
2022-08-01
   |   
Countries: 
South Africa
Publication: 
JAIDS
Background: Tuberculosis preventive therapy (TPT) is recommended for people with HIV infection, including during pregnancy. The effect of TPT exposure at conception and during pregnancy is poorly documented. Methods: We report pregnancy outcomes among South African women...

The association of gestational diabetes with HIV infection and tuberculosis in Indian women

Post Date: 
2022-08-01
   |   
Countries: 
India
Publication: 
The American Journal of Tropical Medicine and Hygiene
Infection of HIV is associated with an increased diabetes risk, which also increases tuberculosis risk. It is unknown if similar associations exist with gestational diabetes (GDM). We screened pregnant women living with and without HIV for GDM using oral glucose tolerance testing. In a subgroup of...

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