Botswana Pediatric Respiratory Disease and Bloodstream Infection Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Harvard School of Public Health

ClinicalTrials.gov Identifier:

NCT00197691

First received: September 13, 2005

Last updated: March 30, 2012

Last verified: March 2012

History of Changes

Purpose

The purpose of this study is to learn about lower respiratory tract and bloodstream diseases among infants born to HIV positive mothers in Botswana. Study factors include how commonly infants get these diseases, the causes, and outcomes. The study will also try to measure the protective effect, if any, of breast feeding on respiratory disease illness and deaths.

Condition	Intervention
HIV Infections Respiratory Tract Diseases Sepsis	Procedure: blood draws, etc.


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Botswana Pediatric Respiratory Disease and Bloodstream Infection

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:

OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE [ Time Frame: Between birth and 2 years of life ] [ Designated as safety issue: No ]
MORTALITY; EPISODES OF SUSPECTED PNEUMONIA; BACTEREMIA; PRESENCE OF NASOPHARYNGEAL VIRAL PATHOGENS; OROPHARYNGEAL COLONIZATION WITH BACTERIAL PATHOGENS


Study Start Date:	March 2001
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

LIVEBORN INFANT IN THE MASHI PMTCT TRIAL

Criteria

Inclusion Criteria:

Participation in parent study, "Mashi" HIV vertical transmission prevention study for pregnant Botswana women and their infants

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197691

Locations


Botswana
Princess Marina Hospital
Gaborone, Botswana

Sponsors and Collaborators

Harvard School of Public Health

Investigators


Principal Investigator:	Shahin Lockman, MD	Harvard School of Public Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shapiro RL, Smeaton L, Lockman S, Thior I, Rossenkhan R, Wester C, Stevens L, Moffat C, Arimi P, Ndase P, Asmelash A, Leidner J, Novitsky V, Makhema J, Essex M. Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana. J Infect Dis. 2009 Feb 1;199(3):414-8. doi: 10.1086/596034.

Shapiro RL, Lockman S, Kim S, Smeaton L, Rahkola JT, Thior I, Wester C, Moffat C, Arimi P, Ndase P, Asmelash A, Stevens L, Montano M, Makhema J, Essex M, Janoff EN. Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana. J Infect Dis. 2007 Aug 15;196(4):562-9. Epub 2007 Jul 9.


Responsible Party:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197691 History of Changes
Other Study ID Numbers:	HSC 10027/000BOTS
Study First Received:	September 13, 2005
Last Updated:	March 30, 2012
Health Authority:	Botswana: Ministry of Health

Keywords provided by Harvard School of Public Health:


HIV infected mothers Infants at risk of HIV-infection Infant lower respiratory tract disease Infant bloodstream infection

Additional relevant MeSH terms:


Infection Communicable Diseases HIV Infections Respiration Disorders Respiratory Tract Diseases Lentivirus Infections Retroviridae Infections	RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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