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
  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:


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
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

No publications provided by Harvard School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Respiration Disorders
Respiratory Tract Diseases
Sepsis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014