A Multicenter Phase II/II 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

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2018-01-23
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Dr. Vidya Mave is leading this clinical trial evaluating the safety and efficacy of a new recombinant BCG vaccine.

Assessing the Impact of the Fogarty HIV-TB Training Program at the Byramjee Jeejeebhoy Government Medical College, Pune, India

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2018-01-19
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This study was terminated in January 2021. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Johns Hopkins University was funded in 2013 to establish a new post-doctoral training program in HIV-TB epidemiology, clinical and...

Perceptions of HCWs on Barriers and Opportunities to Airborne Infection Control Guideline Implementation

Post Date: 
2017-12-07
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This study was terminated in December 2020 It was funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. Led by Dr. Nishi Suryavanshi, this qualitative, cross-sectional study is assessing healthcare worker (HCW) perceptions about...

A5302: BioBank for Surrogate Marker Research for TB (B-SMART)

Post Date: 
2017-11-21
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This study was terminated September 1, 2021. This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. A5302 is a multi-center trial of the AIDS Clinical Trials Group (ACTG) in collaboration...

The Role of GeneXpert in Bacterial Diagnosis of Spinal Tuberculosis

Post Date: 
2017-10-26
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This study was teriminated June 19, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. India has the maximum burden of tuberculosis (TB) in the world. In 2014, there were an estimated 9.6 million incident...

Lipid Mediators of Inflammation in TB and TB-Diabetes

Post Date: 
2017-10-02
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This study was terminated August 1, 2019. It was funded and conducted under the U.S. National Institutes of Health and is nested within Impact of Diabetes on TB Treatment Outcomes. Dr. Jonathan Golub was the PI. Studies have shown that individuals with...

Characteristics Associated with Mobile Phone Usage among TB Populations in Pune, India

Post Date: 
2017-10-02
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With 8.6 million people affected worldwide in 2012, the control and prevention of tuberculosis (TB) has become an international priority. In order to reduce burdens and achieve global goals for TB control, new and innovative tools are necessary. With a growing number of mobile phone subscriptions...

Targeting Mycobacterium Tuberculosis Persisters by Enhancing Stringent Response-specific Cellular Immunity

Post Date: 
2017-09-11
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C-TRIUMPH nested study begins to see if stringent response antigen is enhanced while treating drug-susceptible TB using the first-line anti-TB regimen.

Investigating Maternal Antibodies to Modify Infant Tuberculosis Acquisition

Post Date: 
2017-08-29
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New study in Pune, India, aims to identify the profile of TB antibodies between mothers and infants, and to see if the presence of antibodies lowers risk of infant infection.

Validation of Transcriptional Signature to Predict Active TB Disease among Advanced HIV Patients

Post Date: 
2017-08-15
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This study was terminated June 20, 2021. There have been tremendous advances in the diagnosis of patients with tuberculosis (TB) based on nucleic acid amplification of bacteria in the sputum. The GenXpert MTB/RIF provides results in 2 hours. However, in HIV-infected sputum...

Association of Lipid Mediators of Inflammation with TB Treatment Outcomes

Post Date: 
2017-08-03
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This study was terminated July 22, 2019. This study used stored samples from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB...

Optimizing Treatment to Improve TBM Outcomes in Children: Substudy on Clinical Profile and CSF Biorepository of the Pediatric Suspected Meningitis Cases

Post Date: 
2017-07-18
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This sub-study is being led by PIs Dr. Kelly Dooley and Dr. Chhaya Valvi. Meningoencephalitis is associated with significant morbidity and mortality. Several viruses, bacteria, and fungal pathogens including Neisseria meningitidis, Streptococcus pneumoniae, Mycobacterium...

A5349: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial

Post Date: 
2017-06-05
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This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This is an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 non-inferiority trial. Primary Objectives: To evaluate the efficacy of a rifapentine-...

Understanding Quality of Life during and Loss to Follow-up from Drug-Resistant Tuberculosis Treatment in Pune, India

Post Date: 
2017-05-15
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This study will examine a) risk factors for loss to follow-up from DR-TB treatment, b) actively trace DR-TB patients lost to follow-up from treatment and c) establish a prospective observational cohort of MDR-TB, XDR-TB and DS-TB patients as well as healthy controls nested within ongoing...

Risk Factors for Unfavourable Treatment Outcomes among Multidrug-Resistant Tuberculosis Patients in Public Sector Treatment in Pune

Post Date: 
2017-03-29
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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. This study seeks to identify risk factors associated with unfavourable treatment outcomes (death, treatment failure, default, XDR-TB) among multidrug-resistant...

Biomarkers for Tuberculosis Diagnosis and Treatment Response

Post Date: 
2017-03-24
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This study is conducted by the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH) under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. Aims: ...

MDR-TB Free: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy

Post Date: 
2017-03-24
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This study is also known as MDR-TB MUKT: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy. Purpose: To establish an observational cohort of MDR-TB cases and household contacts with accompanying biorepository at PD Hinduja National...

Impact of HIV and Diabetes Mellitus on TB Drug Resistance and Recurrence

Post Date: 
2017-03-02
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This study was terminated in January 2021. Tuberculosis (TB) is the leading cause of mortality globally. With increasing burden of HIV and diabetes mellitus (DM), there is a critical need to understand the microbial response and ensuing disease dynamics of TB in the HIV-infected and diabetic host...

Multicenter Study of the Accuracy of the BD MAX MDR-TB Assay for Detection of M. tuberculosis Complex and Mutations Associated with Resistance to Rifampin or Isoniazid

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2017-03-01
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In a multi-country study, we are assessing the accuracy of the BD MAX rapid MDR-TB assay to detect rifampin and isoniazid resistance.

TREAT Asia Observational Database

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2017-02-09
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Study conducted under the TREAT Asia Network and funded by amfAR. The TREAT Asia Observational Database's primary study objective is to: Examine HIV natural history, including the relationship between access to ART, demographics, and...

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Immunologic effects of pregnancy on M. tuberculosis: methodology of an observational cohoStages of pregnancy and HIV affect diagnosis of tuberculosis infection and Mycobacterium tuberculosis (MTB)-induced immune response: Findings from PRACHITi, a cohort

Post Date: 
2021-09-21
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...

Health Systems and Tuberculosis Control

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2021-09-20
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Essential Tuberculosis
This chapter discusses the relationship between health systems and organization of tuberculosis (TB) control, which is generally a part and parcel of a health system. It juxtaposes the six building blocks of a health system identified by the World Health Organization (WHO) on WHO’s End TB...

Resistance to Mycobacterium tuberculosis infection among household contacts: a multinational study

Post Date: 
2021-09-15
Publication: 
Clinical Infectious Diseases
Background Some contacts of patients with tuberculosis remain negative on tests for tuberculosis infection, despite prolonged exposure, suggesting they might be resistant to Mycobacterium tuberculosis infection. The objective of this multinational study was to estimate the proportion of household...

Modern lineages of Mycobacterium tuberculosis were recently introduced in western India and demonstrate increased transmissibility

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2021-08-21
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Open Forum Infectious Diseases
Background Mycobacterium tuberculosis (Mtb) transmissibility may vary between lineages (or variants) and this may contribute to the slow decline of tuberculosis (TB) incidence. The objective of our study was to compare transmissibility across four major lineages (L1-4) of Mtb among participants...

Urine LAM Testing in Advanced HIV-Infected Adults in a Trial of Empiric TB Therapy

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2021-08-15
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Clinical Infectious Diseases
Background The urine lipoarabinomannan (LAM) antigen test is a tuberculosis (TB) diagnostic test with highest sensitivity in individuals with advanced human immunodeficiency virus (HIV). Its role in TB diagnostic algorithms for HIV-positive outpatients remains unclear. Methods The AIDS Clinical...

Utility of the interferon-gamma release assay for latent tuberculosis infection screening among indian health-care workers

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2021-07-13
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Indian Journal of Community Medicine
Background: The utility of interferon-gamma release assays (IGRAs) for latent tuberculosis infection (LTBI) screening among health-care workers (HCWs) in low- and middle-income countries (LMICs) remains unclear. Methods: This was a prospective cohort study among HCW trainees...

Targeted next generation sequencing directly from sputum for comprehensive genetic information on drug resistant Mycobacterium tuberculosis

Post Date: 
2021-07-13
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Tuberculosis
Background: Timely drug resistance detection is essential to global tuberculosis management. Unfortunately, rapid molecular tests assess resistance to only a few drugs, with culture required for comprehensive susceptibility test results. Methods: We evaluated targeted next generation sequencing (...

Linezolid resistance mycobacterium tuberculosis isolates at a tertiary center in Mumbai, India

Post Date: 
2021-07-01
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Indian Journal of Medical Research
Background & objectives: Linezolid (LZD) is increasingly being used in tuberculosis (TB) treatment. However, LZD resistance has already been reported, which is highly alarming, given its critical therapeutic role. This study was aimed to phenotypically and genotypically assess LZD resistance in...

Integrative multi-omics reveals serum markers of tuberculosis in advanced HIV

Post Date: 
2021-06-08
Publication: 
Frontiers in Immunology
Tuberculosis (TB) accounts for disproportionate morbidity and mortality among persons living with HIV (PLWH). Conventional methods of TB diagnosis, including smear microscopy and Xpert MTB/RIF, have lower sensitivity in PLWH. Novel high-throughput approaches, such as miRNAomics and metabolomics,...

Diabetes Mellitus and Tuberculosis Treatment Outcomes in Pune, India

Post Date: 
2021-04-01
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Open Forum Infectious Diseases
Background Diabetes mellitus (DM) increases the risk of tuberculosis (TB) disease. Knowledge of the impact of DM on TB treatment outcomes is primarily based on retrospective studies. Methods We conducted a prospective cohort study of new pulmonary TB patients with and without DM (TB-DM and TB only...

Unhealthy alcohol use independently associated with unfavorable TB treatment outcomes among Indian men

Post Date: 
2021-03-10
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International Journal of Tuberculosis and Lung Disease
This study by Samyra Cox and colleagues highlights the need for integrating effective alcohol interventions into TB care.

Drug susceptibility patterns of Mycobacterium tuberculosis from adults with Multidrug-Resistant Tuberculosis and Implications for a Household Contact Preventive Therapy Trial

Post Date: 
2021-02-24
Publication: 
BMC Infectious Diseases
Background Drug susceptibility testing (DST) patterns of Mycobacterium tuberculosis (MTB) from patients with rifampicin-resistant tuberculosis (RR-TB) or multidrug-resistant TB (MDR-TB; or resistant to rifampicin and isoniazid (INH)), are important to guide preventive therapy for their household...

A two-gene signature for tuberculosis diagnosis in persons with advanced HIV

Post Date: 
2021-02-21
Publication: 
Frontiers in Immunology
Background: Transcriptomic signatures for tuberculosis (TB) have been proposed and represent a promising diagnostic tool. Data remain limited in persons with advanced HIV. Methods: We enrolled 30 patients with advanced HIV (CD4 <100 cells/mm3) in India; 16 with active TB and 14 without. Whole-...

Systemic Inflammation in Pregnant Women With Latent Tuberculosis Infection

Post Date: 
2021-01-27
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Frontiers in Immunology
Background: Recent studies in adults have characterized differences in systemic inflammation between adults with and without latent tuberculosis infection (LTBI+ vs. LTBI-). Potential differences in systemic inflammation by LTBI status has not been assess in pregnant women. Methods: We conducted a...

Higher interleukin-6 levels and changes in transforming growth factor-β are associated with lung impairment in pulmonary tuberculosis

Post Date: 
2021-01-18
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ERJ Open Resource
Higher levels of IL-6 and slow-to-resolve TGF-β are associated with lung impairment in treated tuberculosis. These results have important implications for clinical trials of immunomodulatory therapies to prevent tuberculosis-associated lung disease. http://openres.ersjournals.com/lookup/doi/...

Detection of genital tuberculosis among women with infertility using best clinical practices in India: An implementation study

Post Date: 
2021-01-15
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Indian Journal of Tuberculosis
Background Diagnosis of genital tuberculosis (TB) as a cause of infertility still remains a diagnostic dilemma for clinicians, as no standard guidelines exist. The recently proposed best practices for genital TB diagnosis have not been evaluated yet in India. Objectives To implement best practices...

Stages of pregnancy and HIV affect diagnosis of tuberculosis infection and Mycobacterium Tuberculosis (MTB)-induced immune response: Findings from PRACHITi, a cohort study in Pune, India

Post Date: 
2021-01-11
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IJID
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...

Higher IL-6 Levels and Changes in TGF-β are Associated with Lung Impairment in Pulmonary Tuberculosis

Post Date: 
2021-01-08
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ERJ
Pulmonary tuberculosis (PTB) is associated with granuloma formation, necrosis and cavitation in lung tissue. Lung injury in PTB can persist despite microbiological cure and is associated with chronic obstructive pulmonary disease (COPD) independent of smoking exposure[1]. Furthermore, pulmonary...

Measuring TB drug levels in the hair in adults and children to monitor drug exposure and outcomes

Post Date: 
2021-01-01
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International Journal of Tuberculosis and Lung Disease
INTRODUCTION: Testing for anti-TB drugs in small hair samples may serve as a non-invasive tool to measure cumulative drug exposure and/or adherence, as these determine treatment success. We aimed to assess how well hair assays of TB drugs predict TB treatment outcomes.METHODS: A small thatch of...

Nevirapine pharmacokinetics in HIV-infected persons receiving rifapentine and isoniazid for TB prevention

Post Date: 
2020-11-26
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The Journal of Antimicrobial Chemotherapy
Background: The use of rifamycin antibiotics for TB prevention carries a risk of detrimental drug-drug interactions with concomitantly used ART. Objectives: To evaluate the interaction of the antiretroviral drug nevirapine in combination with 4 weeks of daily rifapentine and isoniazid for TB...

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