Pediatrics

Studies/Projects
Publications

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...

T Cell Biomarkers and T-regulatory Responses to Pediatric TB

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2019-11-21

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The goals of this study are to: Validate host T cell biomarkers for diagnosis of pediatric TB Investigate the phenotype and functions of T-regulatory cells in pediatric TB We will use cryopreserved PBMC samples from CTRIUMPH cohorts: Pediatric unconfirmed TB, confirmed TB, latest Tb, and no TB...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

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2019-08-19

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Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

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2019-08-19

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Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB...

Immune Correlates of LTBI in HIV-exposed Infants

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2019-04-29

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About 2 billion people worldwide harbor asymptomatic latent TB infection (LTBI), activation of which results in progression to TB disease. In areas of high tuberculosis (TB) prevalence, infants and young children have a 3-fold higher risk of progression and death from TB at age < 5 years...

Prevalence of Tuberculosis in Severely Malnourished Indian Children

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2018-12-18

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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. PIs are Robert Bollinger, MD, MPH; Dr. Muralidhar Tambe, BJGMC Severely malnourished children are vulnerable population for communicable and non-communicable...

Host RNA Expression for Diagnosis and Monitoring of Pediatric TB in Africa and India

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2018-12-13

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We are leveraging the RePORT platform by including a cohort of Indian children together with South African children in a large validation study to study on changes in gene expression profiles during treatment for TB

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

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2018-07-12

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Bharati Vidyapeeth Medical College

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...

Optimal Approach for TB Screening among HIV Infected Indian Children

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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

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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

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2018-04-19

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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. Dr. Aaron Milstone is the PI, and Dr. Amita Gupta and Yuka Manabe are Co-PIs. The Study...

Investigating Maternal Antibodies to Modify Infant Tuberculosis Acquisition

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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.

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

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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...

TREAT Asia Pediatric HIV Observational Database

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2017-02-09

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Studies conducted under the TREAT Asia Network and funded by amfAR. TREAT Asia Pediatric HIV Observational Database (TApHOD) is a collaborative observational cohort study of infants, children, and adolescents living with HIV. TApHOD study participants are...

Healthcare-Associated Sepsis in the Neonatal Intensive Care Unit in Pune, India

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2017-01-17

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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. Johns Hopkins neonatologist Dr. Julia Johnson is lead investigator for a systematic study of the...

Transcriptomic and Metabolomic Analysis of Microbiologically Confirmed Pediatric Tuberculosis Patients and Uninfected Household Contacts

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2016-09-01

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This study was terminated in June 2020. 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...

Adherence to Indian National Guidelines for Isoniazid Chemoprophylaxis among Pediatric Contacts of Pulmonary Tuberculosis Cases

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2016-07-06

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This study was terminated June 19, 2019. The primary objective of the study was to assess the implementation of the Indian Revised National Tuberculosis Programme's (RNTCP) guidelines regarding isoniazid preventive treatment (IPT) for children under 6 years of age who had been in contact with...

A Randomized Therapeutic Interventional Comparative Study between Three Different Modalities of Paediatric Antitubercular Treatment

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2016-06-13

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This study was terminated July 6, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. This study evaluated three different TB treatment regimens in children attending Sassoon General Hospital in Pune, India. A...

Barriers to Early Treatment Initiation in Childhood Tuberculosis in High Incidence Setting

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2016-04-21

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This study was terminated October 25, 2019. Funded by the Fogarty International Center and led by PI Dr. Chhaya Tukaram Valvi, the aim of this study is to evaluate the time to treatment initiation and barriers to early treatment initiation in childhood tuberculosis. TB...

Barriers to Implementation of Isoniazid Preventive Treatment (IPT) in Pediatric Contacts of Sputum Positive Adults with Tuberculosis

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2016-03-24

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This study was terminated January 3, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. Young children infected with M.tuberculosis can rapidly progress to pulmonary and extrapulmonary disease with high rates of mortality and...

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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...

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...

Concomitant pulmonary disease is common among patients with extrapulmonary TB

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2022-08-12

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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.

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

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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...

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-...

Validation of New Interactive Nutrition Assistant - Diet in India Study of Health (NINA-DISH) FFQ with multiple 24-h dietary recalls among pregnant women in Pune, India

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2021-11-02

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The British Journal of Nutrition

Adequate dietary intake is critical to prevent adverse pregnancy outcomes. India has a high burden of maternal and child morbidity and mortality, but there is a lack of adequate tools to assess dietary intake. We validate an FFQ, New Interactive Nutrition Assistant - Diet in India Study of Health (NINA-DISH), among pregnant women living with and without HIV in Pune, India.

Tuberculosis in children, adolescents, and women

Post Date:

2020-02-27

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Lancet Respiratory Medicine

In this Lancet Respiratory Medicine commentary, Dr. Amita Gupta and colleagues note that TB prevalence among children, adolescents, and women isn't well documented. This poses big challenges for the goal of TB elimination.

High prevalence of late presentation of ART-naïve perinatally infected children for care in Pune, India

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2020-02-19

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AIDS Care

AIDS Care : There is an urgent need to identify strategies that improve linkage of perinatally infected ART-naïve children to care, and earlier than what is currently observed.

Transcriptomic profiles of confirmed pediatric tuberculosis patients and household contacts identifies active tuberculosis, infection, and treatment response among Indian children

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2019-12-04

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Journal of Infectious Diseases

Journal of Infectious Diseases: Gene expression profiles among Indian children with confirmed TB were distinct from those of adults, highlighting the importance of including distinct populations in differential gene expression models

Challenges in conducting trials for pediatric tuberculosis meningitis: lessons learned in the field

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2019-10-01

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International Journal of Tuberculosis and Lung Disease

International Journal of Tuberculosis and Lung Disease: Researchers describe the challenges associated with conducting the first randomized clinical trial of antimicrobial agents in pediatric tuberculosis meningitis.

Delays and barriers to early treatment initiation for childhood tuberculosis in India

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2019-10-01

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International Journal of Tuberculosis and Lung Disease

BACKGROUND: India accounts for 27% of global childhood tuberculosis (TB) burden. Understanding barriers to early diagnosis and treatment in children may improve care and outcomes. METHODS: A cross-sectional study was performed among 89 children initiated on anti-TB treatment from a public hospital...

Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons

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2019-08-15

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PLOS Medicine

PLOS Medicine: Dr. Amita Gupta and colleagues discuss the scientific and ethical basis for including pregnant and lactation women, children, and HIV+ patients in tuberculosis therapeutic clinical trials.

Long-acting or extended-release antiretroviral products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women: knowledge gaps and research priorities

Post Date:

2019-07-15

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Lancet HIV

Lancet HIV : This paper summarizes findings of the Long acting/Extended Release Antiretroviral Resource Program workshop, and offers recommendations for developing ARV products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women

HIV testing uptake among the household contacts of multidrug-resistant tuberculosis index cases in eight countries

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2019-01-07

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International Journal of Tuberculosis and Lung Disease

International Journal of Tuberculosis and Lung Disease : The Indo-JHU Clinical Research Parentership participated in this multinational study to determine if it's feasible to provide HIV testing for household contacts of MDR-TB cases.

Barriers to screening and isoniazid preventive therapy for child contacts of tuberculosis patients

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2018-10-01

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International Journal of Tuberculosis and Lung Disease

Universal, timely TB screening and IPT for exposed children are urgently needed to reduce pediatric TB in India

Loss to follow‐up and mortality among HIV‐infected adolescents receiving antiretroviral therapy in Pune, India

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2018-06-25

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HIV Medicine

Over 6 years, one-third of HIV+ adolescents in this study discontinued medical treatment, indicating a critical need for retention counselling and closer clinical monitoring.

Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial

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2018-04-19

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Trials

Trials: Evidence for TB treatment in kids is largely based on adult studies. The SHINE study aims to fix this

Mobile phone incentives for childhood immunizations in rural India

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2018-03-19

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Pediatrics

In Pediatrics: Incentives and technology can improve immunization coverage in young children in resource-poor settings.

Suboptimal antituberculosis drug concentrations and outcomes in small and HIV‐coinfected children in India: Recommendations for dose modifications

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2017-12-16

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Clinical Pharmacology and Therapeutics

This work aimed to evaluate the once-daily antituberculosis treatment as recommended by the new Indian pediatric guidelines. Isoniazid, rifampin, and pyrazinamide concentration-time profiles and treatment outcome were obtained from 161 Indian children with drug-sensitive tuberculosis...

Isoniazid concentrations in hair and plasma area-under-the-curve exposure among children with tuberculosis

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2017-12-07

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PLOS One

PLOS One: Mave and colleagues compared TB drug exposure in plasma and hair samples among a small cohort of children.

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