India

With a population of more than one billion, India is the second largest country in the world, represents 16% of the global population, and the national average for life expectancy is only 65 years. India leads the world in the largest absolute burden of TB, ranks third for HIV (behind South Africa and Nigeria), and ranks second for diabetes. The country receives funding to support HIV/AIDS prevention, treatment and care programs under the US President's Emergency Plan for AIDS Relief (PEPFAR).

Our Indo-JHU Clinical Research Partnership is dedicated to reversing poor patient outcomes. With operations based in Pune, our extensive research portfolio is directed by Dr. Amita Gupta (Baltimore, MD), with onsite direction from Dr. Vidya Mave, Dr. Nishi Suryavanshi, and Dr. Nikhil Gupte (Pune). The Indo-JHU Partnership employs more than 200 people and, in addition to our memberships in consortia with many esteemed Indian research institutions, we have formal agreements with:

Byramjee Jeejeebhoy Government Medical College, and Sassoon General Hospital (BJGMC). Pune, India
DY Patil Medical College, Hospital and Research Center. Pune, India
National Institute for Research in Tuberculosis. Chennai, India
PD Hinduja Hospital and Medical Group. Mumbai, India
Medanta The Medicity. Gurgaon, India
KEM Hospital. Pune, India
Bharati Vidyapeeth Medical College. Pune, India

CCGHE WORK IN INDIA

Studies/Projects
Publications

ACTIV-2d/A5407 - A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 (SCORPIO-HR)

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2023-04-11

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COVID-19 is a disease caused by infection with a coronavirus called SARS-CoV-2. COVID-19 affects people in different ways. Infected people have had a wide range of symptoms reported – from no symptoms or mild symptoms to severe illness needing hospitalization and sometimes death. Severe illness is...

HIV, Gestational Diabetes and TB in Pregnancy (PraGaTHi)

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2023-02-27

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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

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2023-01-24

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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...

Assessing prevalence and risk of lung morbidities including lung nodules and cancer using non contrast CT among PLHIV in Pune, India

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2022-11-25

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Primary objective Determine the prevalence of pulmonary nodules, including lung cancer using NCCT. Determine the risk of pulmonary nodules, including lung cancer using NCCT. Evaluate the association of smoking, immune suppression, ART, and TB with the prevalence and risk of NCCT-diagnosed pulmonary...

ACCELERATE

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2022-09-08

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Under the directives of PEPFAR, with support from USAID, and in collaboration with NACO, the ACCELERATE program provides HIV/AIDS services for high-risk populations including key populations affected by HIV throughout India and technical assistance (TA) to the national, state, and district HIV/AIDS...

Kidaba Thawai (Fearless Souls) Documentary

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2022-09-08

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The documentary Kidaba Thawai is based on ACCELERATE's intervention - an Adolescent Friendly Health Center (AFHC) in Imphal, Manipur. The documentary discusses AFHC's comprehensive health care delivery model (HIV and non-HIV services) which contributes to the holistic development of adolescents. A...

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.

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2022-05-08

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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

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2022-01-10

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Hinduja Hospital

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...

Prevalence of gestational diabetes (GDM) and postpartum diabetes (DM) and their risk factors at Sassoon General Hospital and Byramjee Jeejeebhoy Government Medical College in Pune, India

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2021-12-19

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Primary objective: To determine the prevalence of GDM in a population of women in our hospital To identify the risk factors for GDM and determine the prevalence of GDM risk factors in a population of women screened for GDM and their association with GDM To determine the incidence and time course 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)

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2021-11-02

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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

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2021-11-02

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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

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2021-10-18

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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

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2021-08-12

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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

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2021-06-21

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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

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2021-06-15

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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) (...

P2026: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum

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2021-05-18

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IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women, studied the PK of more than 25 HIV and TB drugs in these women and published 27 manuscripts presenting these data. P1026s data was cited in 32% of the 76 perinatal...

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

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2021-04-26

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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

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2021-04-05

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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

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2021-04-01

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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...

Effect of Neighborhoods and Peer Networks on substance use and violence among adolescents living with and without HIV in India

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2021-01-28

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Purpose of the study: A strong bidirectional association exists between substance use, various forms of violence and HIV. Substance use accounts for 0.8% of the burden of disease measured in disability adjusted life years (DALYs) among adolescents in South Asia. Violence among adolescents living...

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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

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2023-09-13

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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

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2023-05-19

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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...

Challenges with the use of Xpert HPV as a screening tool for oral HPV among people living with HIV (PLHIV): experiences from Pune, India

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2023-05-04

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BMC Infectious Diseases

Background: People living with HIV (PLHIV) are at higher risk for human papillomavirus (HPV)-related oropharyngeal cancers compared to the general population. Xpert HPV test is a polymerase chain reaction (PCR) assay capable of rapid HPV detection. Performing the assay requires minimal intervention...

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

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2023-04-26

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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...

Inflammatory profile associated with insulin resistance in non-overweight versus overweight people living with HIV (PLWH)

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2023-04-21

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Diabetes & Metabolic Syndrome

Background People living with HIV have greater diabetes (T2DM) than the general population despite lower prevalence of overweight/obesity. Both insulin resistance (IR), a T2DM precursor, and HIV are independently associated with chronic inflammation. Inflammation may be a pathophysiological link...

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

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2023-04-17

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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...

Integration of a geospatially targeted community-based testing approach with respondent-driven sampling to identify people who inject drugs living with HIV and HCV in Patti and Gorakhpur, India

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2023-04-14

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Drug Alcohol Dependency

Background: Respondent-driven sampling (RDS), a network recruitment approach, is effective at reaching people who inject drugs (PWID), but other strategies may be needed to reach PWID at risk or living with HIV and/or Hepatitis C (HCV). We examined the impact of integrating geospatially targeted...

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

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2023-04-01

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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

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2023-03-17

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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-...

Pro-inflammatory and pro-resolving lipid mediators of inflammation in HIV: effect of aspirin intervention

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2023-03-01

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eBioMedicine

Background: Persons with HIV (PWH) have an increased risk of cardiovascular disease (CVD) compared to HIV-seronegative individuals (SN). Inflammation contributes to this risk but the role of lipid mediators, with central roles in inflammation, in HIV infection remain to be established; further...

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

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2023-01-12

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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

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2023-01-05

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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

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2023-01-04

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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...

Self-Reported Antiretroviral Adherence: Association with Maternal Viral Load Suppression in Postpartum Women Living with HIV-1 from Promoting Maternal and Infant Survival Everywhere (PROMISE), a Randomized Controlled Trial in Sub-Saharan Africa and India

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2023-01-01

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Journal of Acquired Immune Deficiency Syndrome

Introduction: Optimal adherence to antiretroviral therapy (ART) is crucial to promoting maternal–infant health. Setting: Fourteen sites in 7 countries within sub-Saharan Africa and India. Methods: The multicomponent, open-label strategy PROMISE trial enrolled breastfeeding mother–infant pairs not...

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

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2022-12-22

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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...

Virological Failure among People living with HIV Receiving Second-Line Antiretroviral Therapy in Pune, India

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2022-12-17

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BMC Infectious Diseases

Background The number of people receiving second-line antiretroviral therapy (ART) has increased as global access to ART has expanded. Data on the burden and factors associated with second-line ART virologic failure (VF) from India remain limited. Methods We conducted cross-sectional viral load (VL...

Metabolites enhance innate resistance to human Mycobacterium tuberculosis infection

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2022-11-22

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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...

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

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2022-11-01

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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...

Randomized Clinical Trial of High Dose Rifampicin with or without Levofloxacin versus Standard of Care for Paediatric Tuberculous Meningitis: The TBM-KIDS Trial

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2022-10-29

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Clinical Infectious Diseases

Background Pediatric tuberculous meningitis (TBM) commonly causes death or disability. In adults, high-dose rifampicin may reduce mortality. The role of fluoroquinolones remains unclear. There have been no antimicrobial treatment trials for pediatric TBM. Methods TBM-KIDS was a phase 2 open-label...

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

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2022-10-26

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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...

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