Study/Projects - Pediatrics

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

Post Date:

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

Post Date:

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)

Post Date:

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)

Post Date:

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

Post Date:

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

Post Date:

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

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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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

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.

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...

TREAT Asia Pediatric HIV Observational Database

Post Date:

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

Post Date:

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

Post Date:

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

Post Date:

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

Post Date:

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

Post Date:

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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