Pediatrics

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 patients living with HIV compared with 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 patients living with HIV compared with 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 disease. Diagnosis of TB among...

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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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 are Dr...

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. Diagnosis of TB disease is...

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

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 Investigator is...

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 tuberculosis, Herpes...

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 enrolled and followed at selected TREAT...

Shorter Treatment for Minimal TB in Children (SHINE)

Post Date: 
2017-01-17
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This is a multicountry study being conducted in India, South Africa, Uganda, and Zambia. The principal objective is to determine whether the standard 6 month regimen (8 weeks HRZ(E) followed by 16 weeks HR) can be reduced with similar efficacy, to 4 months (8 weeks HRZ(E) followed by 8 weeks HR),...

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

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2016-09-01
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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. The objectives for this study are to: Assess the...

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

Post Date: 
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 convenience sample size of n=100 children...

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 diagnosis in children is...

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 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 morbidity. Studies worldwide have demonstrated that IPT not...

Salud al Dia

Post Date: 
2014-11-01
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This initiative is intended to address healthcare disparities among Latino children in Baltimore by increasing engagement of limited English proficiency (LEP) Latino parents in primary healthcare. Specifically, we are looking at whether using in-person and technology-based support interventions...

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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
Publication: 
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

Preventable losses: Infant mortality increases in Venezuela

Post Date: 
2019-01-24
Publication: 
Lancet Global Health
The health-care system collapse underway in Venezuela is a cause of utmost concern for its people and, increasingly, for the wider region. Declines in provision of basic services, such as childhood immunisation, malaria control, water, sanitation, and nutritional support, have led to increasing...

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

Post Date: 
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

Post Date: 
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

Post Date: 
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

Post Date: 
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

Post Date: 
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

Post Date: 
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 undergoing...

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.

Suboptimal anti-tuberculosis drug concentrations and outcomes in small and HIV coinfected children in India: recommendations for dose modifications

Post Date: 
2017-12-01
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Clinical Pharmacology and Therapeutics
This work aimed to evaluate the once-daily anti-tuberculosis 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 undergoing...

Novel interferon-gamma assays for diagnosing tuberculosis in young children in India

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2017-04-01
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International Journal of Tuberculosis and Lung Disease
Setting: The tuberculin skin test (TST) and interferon-gamma release assays (IGRAs) are used as supportive evidence to diagnose active tuberculosis (TB). Novel IGRAs could improve diagnosis, but data are lacking in young children. Design: Children (age 5 years or...

Isoniazid hair concentrations in children with tuberculosis: a proof of concept study

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2016-06-01
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International Journal of Tuberculosis and Lung Disease
Assessing treatment adherence and quantifying exposure to anti-tuberculosis drugs among children is challenging. We undertook a 'proof of concept' study to assess the drug concentrations of isoniazid (INH) in hair as a therapeutic drug monitoring tool. Children aged <12 years initiated on...

Low Vitamin-D levels combined with PKP3-SIGIRR-TMEM16J host variants is strongly associated with tuberculosis and death in HIV-infected and -exposed infants

Post Date: 
2016-02-12
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PLOS One
Background: This study examined the associations of 25-hydroxyvitamin D and specific host genetic variants that affect vitamin D levels or its effects on immune function, with the risk of TB or mortality in children. Methods: A case-cohort sample of 466 South African infants enrolled in P1041 trial...

Pediatric tuberculous meningitis: model-based approach to determining optimal doses of anti-tuberculosis drugs for children

Post Date: 
2015-10-22
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Clinical Pharmacology and Therapeutics
Pediatric tuberculous meningitis (TBM) is a highly morbid, often fatal disease. Standard treatment includes isoniazid, rifampin, pyrazinamide, and ethambutol. Current rifampin dosing achieves low cerebrospinal fluid (CSF) concentrations, and CSF penetration of ethambutol is poor. In adult trials,...

Source case investigation for children with TB disease in Pune, India

Post Date: 
2014-08-27
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Tuberculosis Research and Treatment
Setting. Contact tracing is broadly encouraged for tuberculosis (TB) control. In many high-burden countries, however, little effort is made to identify contacts of newly diagnosed TB patients. This failure puts children, many of whom live in poor crowded communities, at special risk. Objectives. To...

Challenges to disclosure of HIV status to perinatally infected children: a study of caregiver perspectives in Pune, India

Post Date: 
2014-06-15
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Journal of Pediatric Infectious Diseases
Effective guidelines around disclosure of HIV status are lacking and limited data from India reveal low rates of HIV disclosure to perinatally infected children. This study, conducted in Pune, India, attempts to understand the experiences of caregivers of perinatally infected children around the...

Maternal pneumococcal capsular IgG antibodies and transplacental transfer are lower in South Asian HIV-infected mother-infant pairs

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2014-03-14
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Vaccine
Background: Our understanding of the mother-to-child transfer of serotype-specific pneumococcal antibodies is limited in non-immunized, HIV-positive women. Methods: We compared geometric mean antibody concentrations (GMCs), geometric mean transplacental cord:maternal ratios (GMRs) and proportions...

Mortality and long-term virologic outcomes in children and infants treated with lopinavir/ritonavir

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2013-12-15
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Pediatric Infectious Disease Journal
Background: There is scant data on young children receiving protease inhibitor-based therapy in real-life resource-limited settings and on the optimal timing of therapy among children who survive infancy. Our aim was to evaluate outcomes at the Hospital del Niño, Panama, where children have been...

Pediatric tuberculosis in young children in India: a prospective study

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2013-11-11
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BioMed Research International
Background: India has one of the highest tuberculosis (TB) burdens globally. However, few studies have focused on TB in young children, a vulnerable population, where lack of early diagnosis results in poor outcomes. Methods: Young children (≤ 5 years) with suspected TB were prospectively enrolled...

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Association of latent TB infection in pregnancy with perinatal health outcomes in an Indian cohort

Post Date: 
2019-11-01
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Graham H , Bhosale R, Alexander M, Kinikar A, Khwaja S, Patil N, Mathad J, Shivakoti S, Gupta A. Association of latent TB infection in pregnancy with perinatal health outcomes in an Indian cohort. Poster presentation. 50th Union World Conference on Lung Health. Hyderabad, India. October 30-November...

Inappropriate postpartum weight loss may predict development of active TB: Findings from a cohort study in Pune, India

Post Date: 
2019-11-01
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Alexander M , Bhosale R, Naik S, Gupte N, Jain D, Patil N, Pradhan N, Mave V, Gupta A, Mathad J. Inappropriate postpartum weight loss may predict development of active TB: Findings from a cohort study in Pune, India. Poster presentation. 50th Union World Conference on Lung Health. Hyderabad, India...

High prevalence of tuberculosis infection in children living in households of MDR-TB patients

Post Date: 
2019-10-31
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Kim S , Wu X, Hughes M, Mendoza-Ticona A, Churchyard G, Swindells S, Shah NS, Gupta A, Hesseling A for the A5300/I2003 PHOENIx Feasibility Study Team. High prevalence of tuberculosis infection in children living in households of MDR-TB patients. Short oral presentation. 50th Union World Conference...

Association of latent TB infection in pregnancy with perinatal health outcomes in an Indian cohort

Post Date: 
2019-10-30
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Bhosale R , Graham H, Alexander M, Kinikar A, Khwaja S, Patil N, Gupta A, Mathad J, Shivakoti R. Association of latent TB infection in pregnancy with perinatal health outcomes in an Indian cohort. Poster presentation. 50th Union World Conference on Lung Health. Hyderabad, India. October 30-November...

Antibiotic Use and Drug-Resistant Late-Onset Infections Among Neonates Admitted to Neonatal Intensive Care Units in Pune, India

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2018-08-28
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Agarkhedkar S, Armstrong D, Bharadwaj R, Cox SR, Dohe V, Gupta A, Gupte N, Johnson J, Kadam A, Kinikar A, Malwade S, Manabe Y, Mave V, Milstone A, Parikh T, Rajput U, Randive B, Robinson M , Smith R, Suryavanshi N, Vaidya U, Westercamp M. Antibiotic Use and Drug-Resistant Late-Onset Infections...

Association of Maternal Viral Load and CD4 Count with Perinatal HIV-1 Transmission Risk during Breastfeeding in the PROMISE Postpartum Component

Post Date: 
2018-07-26
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Flynn P, Taha T, Cababasay M, Butler K, Fowler MG, Mofenson L, Owor M, Fiscus S, Stranix-Chibanda L, Coutsoudis A, Gnanshanmugam D, Chakhtoura N, McCarthy K, Mukuzunga C, Makanani B, Moodley D, Nematadzira T, Kusakara B, Patil S, Vhembo T, Bobat R, Mmbaga B, Masenya M, Nyati M, Theron G, Mulenga H...

Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster Randomized Trial

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2018-07-24
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Suryavanshi N, Kadam A, Hegde A, Sivalenka S, Kumar VS, McKenzie-White J, Kanade S, Gupta A, Bollinger RC, Shankar A, Gupte N, Mave V. Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster...

Bloodstream Infections among Neonates Admitted to Neonatal Intensive Care Units in Pune, India

Post Date: 
2018-05-05
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Johnson J , Rajput U, Valvi C, Bharadwaj R, Parikh T, Agarkhedkar S, Robinson M, Randive B, Gupte N, Smith R, Westercamp M, Mave V, Manabe Y, Milstone A, for the CDC SHEPheRD India Study Team. Bloodstream Infections among Neonates Admitted to Neonatal Intensive Care Units in Pune, India. Pediatric...

Inflammation in HIV-Infected Pregnant Women is Associated with Pre-term Birth

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2018-03-07
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Shivakoti R , Gupte N, Kumar NP, Kulkarni V, Balasubramanian U, Bhosale R, Sambarey P, Kinikar A, Bharadwaj R, Patil S, Inamdar S, Suryavanshi N, Babu S, Bollinger R, Gupta A. Inflammation in HIV-Infected Pregnant Women is Associated with Pre-term Birth. CROI 2018. Boston, MA. 2018

Meet the Expert: Managing Tuberculosis in Pregnant Women and Newborns

Post Date: 
2017-10-13
Gupta A. Meet the Expert: Managing Tuberculosis in Pregnant Women and Newborns. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Prevalence of Vitamin D Deficiency among Indian Children with Tuberculosis and Age- and Sex-matched Controls

Post Date: 
2017-10-13
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Kinikar A , Chandanwale A, Dixit S, Jubilus J, Jain S, Bharadwaj R, Mave V, Gupte N, DeLuca A, Gupta A, Bollinger RC. Prevalence of Vitamin D Deficiency among Indian Children with Tuberculosis and Age- and Sex-matched Controls. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico...

Delays and Barriers to Early Treatment Initiation for Childhood Tuberculosis in India

Post Date: 
2017-10-13
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Valvi C , Chandanwale A, Khadse A, Kulkarni R, Kadam D, Dhumal G, Bollinger RC, Deluca A. Delays and Barriers to Early Treatment Initiation for Childhood Tuberculosis in India. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico. October 13, 2017.

Gene Expression Profiles of Pediatric Tuberculosis Patients and Exposed Controls from India

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2017-09-13
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Tornheim JA , Paradkar M, Madugundu A, Gupte N, Kulkarni V, Sreenivasamurthy S, Raja R, Pradhan N, Shivakumar SVBY, Valvi C, Kohli R, Chandrasekaran P, Mave V, Pandey A, Gupta A. Gene Expression Profiles of Pediatric Tuberculosis Patients and Exposed Controls from India. RePORT International...

CTRIUMPh Pediatric Biomarker Substudy

Post Date: 
2017-05-30
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Tornheim J . Paradkar M. CTRIUMPh Pediatric Biomarker Substudy. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

Descriptive Baseline Characteristics, Treatment Outcomes and Biorepository of Pediatric TB Cases in CTRIUMPh-RePORT India Prospective Cohort

Post Date: 
2017-02-03
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Paradkar M , Kavitha D, Shiva Kumar SVBY, Khadse S, Khwaja S, Hari K, Rani N, Thiruvengadam K, Gupte N, Raskar S, Jain D, Suryavanshi S, Kohli R, Kulkarni V, Pradhan N, Sathyamurthi B, Tornheim J, Gupte A, DeLuca A, Mave V, Chandrasekaran P, Gupta A for the CTRIUMPH Study Team. Descriptive Baseline...

Pharmacokinetic Aspects of 3HP in Special Populations

Post Date: 
2016-10-29
Mathad J. Pharmacokinetic Aspects of 3HP in Special Populations. 47th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease. Liverpool, England.

IMPAACT P1078: Background, Design and Baseline Data

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2016-10-29
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Mathad J on behalf of Gupta A and P1078 Study Team. IMPAACT P1078: Background, Design and Baseline Data, 47th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease. Liverpool, England.

Etiology of Acute Febrile Illness among Hospitalized Adults and Children at a Public Tertiary-Care Center in Pune, India

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2016-10-27
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Robinson M , Balasubramanian U, Raichur P, Kadam D, Khadse S, Marbaniang I, Kanade S, Sachs J, Basavaraj A, Bharadwaj R, Kinikar A, Kulkarni V, Kagal A, Gupta A, Mave V. Etiology of Acute Febrile Illness among Hospitalized Adults and Children at a Public Tertiary-Care Center in Pune, India. ID Week...

TB Infection Prevalence, Incidence and Risk Factors among Child and Adult Household Contacts of Adult TB Cases in India

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2016-10-27
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Shivakumar SVBY , Chandrasekaran P, Thiruvengadam K, Gupte N, Mave V, Hannah LE, Kulkarni V, Gupte A, Deluca A, Gomathy NS, Sathyamurthi P, Paradkar M, Kohli R, Meshram S, Kagal A, Suryavanshi N, Ramachandran G, Thomas B, Dolla CK, Subramanyam B, Golub J, Swaminathan S, Gupta A. TB Infection...

A Case-control Study of Household Air Pollution and Tuberculosis in Women and Children in Pune, India

Post Date: 
2016-10-26
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Elf JL , Kinikar A, Khadse S, Mave V, Gupte N, Kulkarni V, Patekar S, Raichur P, Breysse PN, Gupta A, Golub JE. A Case-control Study of Household Air Pollution and Tuberculosis in Women and Children in Pune, India. 47th Union World Conference on Lung Health. International Union for Tuberculosis and...

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