Clinical Research

Clinical Sites:

Hinduja Hospital

This study was terminated on September 27, 2021 Dr. Jeffrey Tornheim is Principal Investigator for this study. There are limited studies available from India on whole genome sequencing (WGS). This is a first-of-its-kind wherein WGS for MTB will be carried out utilizing direct sputum DNA and...

Assessing the Impact of Psychosocial Involvement in Health Care Workers with and without Active Tuberculosis at the Byramjee Jeejeebhoy Government Medical College, Pune, India

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2018-09-13

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This study was terminated effective 9/13/2021 This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. The overall goal is to understand the psychosocial involvement in health care workers with and...

Assessment of Depression and Anxiety among HIV-infected Adolescents in Pune, India

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2018-07-22

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This study is conducted under the TREAT Asia Network and funded by amfAR. PURPOSE The purpose of this study is to estimate the prevalence of depression and anxiety among adolescents living with HIV in India and their determinants. DESIGN...

Evaluating the Source of Neonatal Bloodstream Infections due to Classically Hospital Acquired Pathogens in the Neonatal Intensive Care Unit in Pune, India

Post Date:

2018-07-12

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Bharati Vidyapeeth Medical College

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This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. The PIs for this study are Dr. Julia Johnson of Johns Hopkins and Dr. Shilpa Naik of BJGMC. CoPIs...

Molecular Signatures of Tuberculosis-Diabetes Interaction: Metabolomics Study

Post Date:

2018-06-15

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This study is using 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 consortium. Type 2 diabetes mellitus (DM...

Molecular Signatures of Tuberculosis-Diabetes Interaction: Transcriptomics Study

Post Date:

2018-06-15

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Gut Microbiota of HIV Infected Pregnant Women

Post Date:

2018-06-14

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Birth Outcomes in HIV Both antiretroviral-therapy (ART)-naïve and ART-experienced HIV-infected pregnant women have higher incidences of pre-term birth (PTB) compared to HIV-uninfected women. For example, the global prevalence of PTB is around 8%, while the rates in in HIV-infected...

Optimal Approach for TB Screening among HIV Infected Indian Children

Post Date:

2018-06-11

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This study was terminated May 20, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Determining TB status (ie, uninfected, latent, and active TB disease) is more difficult among children, particularly HIV-infected children...

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB

Post Date:

2018-06-07

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New study will characterize the pharmacokinetics of delamanid using a model-based approach, and evaluate safety and tolerability of over 24 weeks of study treatment in HIV infected and uninfected children.

Implementing the Comprehensive Unit-based Safety Program to Reduce Healthcare-Associated Sepsis in the Neonatal Intensive Care Unit in Pune, India

Post Date:

2018-04-19

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DY Patil

This study is part of CDC's Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program under Domain 7: International HAI and Other Adverse Healthcare Event Prevention. Dr. Aaron Milstone is the PI, and Dr. Amita Gupta and Yuka Manabe are Co-PIs. The Study...

Predictors of Resistance Emergence Evaluation in Multidrug Resistant-Tuberculosis Patients on Treatment (PREEMPT Pilot Study)

Post Date:

2018-03-20

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Indo-JHU Clinical Resarch Partnership is participating with Brazilian colleagues in a 3-year effort led by Boston University to identify what contributes to TB drug resistance.

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

Post Date:

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.

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...

Zika Surveillance among Antenatal Clinic Outpatients in BJ Government Medical College and Sassoon General Hospitals, Pune, India

Post Date:

2017-08-31

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This study was terminated July 21, 2020. Zika virus is a vector-borne disease carried by the mosquito Aedes aegypti . Pregnant women infected with Zika may pass the virus to the fetus, which may cause microcephaly and other severe brain defects. It is also linked to...

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...

Assessing tuberculosis risk in pregnant women from the PRACHITi study using transcriptomics

Post Date:

2022-06-10

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Clinical Infectious Diseases

A new tuberculosis (TB) diagnostic cartridge assay, which detects a 3-gene TB signature in whole blood, was not diagnostic in women with maternal TB disease in India (area under the curve [AUC] = 0.72). In a cohort of pregnant women, we identified a novel gene set for TB diagnosis (AUC = 0.97) and...

A Novel Computer-Based Virtual Counselor-Delivered Alcohol Reduction Intervention : Acceptability, Adaptability and Feasibility among Adults with HIV or TB in Indian Clinical Settings

Post Date:

2022-05-27

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JMIR Formative Research

Background: Unhealthy alcohol use is associated with increased morbidity and mortality among persons with HIV and tuberculosis (TB). Computer-based interventions (CBIs) can reduce unhealthy alcohol use, are scalable, and may improve outcomes among patients with HIV or TB. Objective: We assessed the...

Clinical and Immunological Markers of Pulmonary Impairment among People with HIV(PWH) in India

Post Date:

2022-05-12

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Open Forum Infectious Diseases

Background Despite anti-retroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods 210 adult PWH receiving antiretroviral...

Clinical and Immunological Markers of Pulmonary Impairment among People Living with HIV in India

Post Date:

2022-05-11

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Open Forum Infectious Diseases

Background Despite antiretroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods Two hundred ten adult PWH receiving...

High prevalence of TB infection and disease in child household contacts of adults with rifampin-resistant tuberculosis

Post Date:

2022-05-01

Publication:

Pediatric Infectious Disease Journal

Background: Household contact (HHC) investigation is an important strategy to identify individuals with tuberculosis (TB) exposure, infection and disease, including those who may benefit from tuberculosis preventive therapy (TPT). Data in children exposed to rifampin-resistant TB are limited...

Acute Respiratory Distress Syndrome in an African Intensive Care Unit Setting. A prospective study of prevalence and outcomes

Post Date:

2022-04-19

Publication:

Annals of American Thoracic Society

Acute respiratory distress syndrome (ARDS) is a life-threatening form of respiratory failure accounting for at least 10% of global intensive care unit (ICU) admissions (1–5). The Berlin definition for diagnosing ARDS is expensive for most resource-constrained settings to apply (6–8). There are...

Performance of Xpert MTB/RIF and Xpert Ultra for the diagnosis of tuberculous meningitis among Indian children

Post Date:

2022-04-01

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International Journal of Tuberulosis and Lung Disease

OBJECTIVE: To assess Xpert® MTB/RIF (Xpert) and Xpert® MTB/RIF Ultra (Ultra) performance in diagnosing pediatric tuberculous meningitis (TBM). METHODS: We conducted a study among children with suspected meningoencephalitis in Pune, India. Clinical, radiological, laboratory, and treatment data were...

Cycloserine did not increase depression incidence or severity at standard dosing for MDR-TB

Post Date:

2022-03-24

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European Respitory Journal

In 2018 cycloserine was elevated to World Health Organization (WHO) group B status for multidrug-resistant tuberculosis (MDR-TB), and is recommended in longer MDR-TB treatment regimens [ 1 ]. Inclusion of cycloserine is associated with improved MDR-TB treatment success and reduced mortality, but is...

Shorter treatment for non-severe tuberculosis in African and Indian children

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2022-03-10

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New England Medical Journal

BACKGROUND Two thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen. METHODS We conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-...

Pharmacokinetics and Safety of Three Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women

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2022-03-05

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Clinical Infectious Diseases

Background Pregnancy increases the risk of tuberculosis and its complications. A 3-month regimen of weekly isoniazid and rifapentine (3HP) is safe and effective for tuberculosis prevention in adults and children, including those with HIV, but 3HP has not been evaluated in pregnancy. Methods IMPAACT...

Integrating services for HIV and multidrug-resistant tuberculosis: a global cross-sectional survey among ART clinics in low- and middle-income countries

Post Date:

2022-03-01

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PLOS Global Public Health

Tuberculosis (TB) is the leading cause of death among PLHIV and multidrug-resistant-TB (MDR-TB) is associated with high mortality. We examined the management for adult PLHIV coinfected with MDR-TB at ART clinics in lower income countries. Between 2019 and 2020, we conducted a cross-sectional survey...

A Multicenter, Prospective Cohort Study of the Tuberculosis-Diabetes Interaction

Post Date:

2022-02-15

Publication:

Journal of Infectious Diseases

Background It is unclear whether diabetes or prediabetes affects unfavorable treatment outcomes and death in people with tuberculosis (PWTB). Methods Culture-confirmed, drug-susceptible PWTB, enrolled in the Regional Prospective Observational Research in Tuberculosis (RePORT)–Brazil cohort between...

TB-related Knowledge and Stigma Among Pregnant Women in Low Resource Settings of Pune, India

Post Date:

2022-02-01

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Haiti

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Publication:

The International Journal of Tuberculosis and Lung Disease,

TB is an important cause of maternal morbidity.1 Studies among adults with TB in several countries have consistently demonstrated that a lack of TB-related knowledge and increased stigma can be a barrier to early diagnosis, seeking treatment and treatment adherence.2–6 India has the highest number...

Burden of COVID-19 and Case Fatality Rate in Pune India: An Analysis of First and Second Wave of the Pandemic

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2022-01-22

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IJID Regions

Objective To assess trends in case incidence and fatality rate between the first and second waves, we analyzed programmatic COVID-19 data from Pune city, an epicenter of COVID-19 cases in India. Method The trends of cases incidence, time-to-death and case fatality rate (CFR) were analyzed. Poisson...

Tuberculosis Pathways to Care and Transmission of Multidrug Resistance in India

Post Date:

2022-01-15

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American Journal of Respiratory Critical Care Medicine

Abstract Rationale: India is experiencing a regional increase in cases of multidrug-resistant tuberculosis (MDR-TB). Objectives: Given the complexity of MDR-TB diagnosis and care, we sought to address key knowledge gaps in MDR risk factors, care delays, and drivers of delay to help guide disease...

Host lipidome and tuberculosis treatment failure

Post Date:

2022-01-06

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European Respiratory Journal

Introduction: Host lipids play important roles in tuberculosis (TB) pathogenesis. Whether host lipids at TB treatment initiation (baseline) affect subsequent treatment outcomes has not been well characterised. We used unbiased lipidomics to study the prospective association of host lipids with TB...

Implementation of the Comprehensive Unit-based Safety Program to Improve Infection Prevention and Control Practices in Four Neonatal Intensive Care Units in Pune, India

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2022-01-06

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Publication:

Frontiers in Pediatrics

Objective: To implement the Comprehensive Unit-based Safety Program (CUSP) in four neonatal intensive care units (NICUs) in Pune, India, to improve infection prevention and control (IPC) practices. Design: In this quasi-experimental study, we implemented CUSP in four NICUs in Pune, India, to...

Increased Moxifloxacin Dosing among MDR-TB Patients with Low-Level Resistance to Moxifloxacin did not Improve Treatment Outcomes in a Tertiary Care Center in Mumbai, India

Post Date:

2021-12-23

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Open Forum Infectious Diseases

Background Mycobacterium tuberculosis (Mtb) strains resistant to isoniazid and rifampin (multidrug-resistant tuberculosis [MDR-TB]) are increasingly reported worldwide, requiring renewed focus on the nuances of drug resistance. Patients with low-level moxifloxacin resistance may benefit from higher...

Impact of HIV status on systemic inflammation during pregnancy

Post Date:

2021-11-15

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