Botswana Pediatric Respiratory Disease and Bloodstream Infection Study
March 30, 2012 updated by: Harvard School of Public Health (HSPH)
Botswana Pediatric Respiratory Disease and Bloodstream Infection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gaborone, Botswana
- Princess Marina Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
LIVEBORN INFANT IN THE MASHI PMTCT TRIAL
Description
Inclusion Criteria:
- Participation in parent study, "Mashi" HIV vertical transmission prevention study for pregnant Botswana women and their infants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
Time Frame: Between birth and 2 years of life
|
MORTALITY; EPISODES OF SUSPECTED PNEUMONIA; BACTEREMIA; PRESENCE OF NASOPHARYNGEAL VIRAL PATHOGENS; OROPHARYNGEAL COLONIZATION WITH BACTERIAL PATHOGENS
|
Between birth and 2 years of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shahin Lockman, MD, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1086/519847. Epub 2007 Jul 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2001
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
April 2, 2012
Last Update Submitted That Met QC Criteria
March 30, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- HIV Infections
- Sepsis
- Infections
- Communicable Diseases
- Respiration Disorders
- Respiratory Tract Diseases
Other Study ID Numbers
- HSC 10027/000BOTS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.