HIV InfectionsNCT00197691
Botswana Pediatric Respiratory Disease and Bloodstream Infection Study
An observational study of HIV Infections and Respiratory Tract Diseases, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- HIV Infections, Respiratory Tract Diseases, Sepsis
- What is being tested?
- blood draws, etc.
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteBotswana
- Study dates
- Mar 2001to Oct 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: LIVEBORN INFANT IN THE MASHI PMTCT TRIAL
Who may be able to join
- Participation in parent study, "Mashi" HIV vertical transmission prevention study for pregnant Botswana women and their infants
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- HIV Infections, Respiratory Tract Diseases, Sepsis
- Being tested
- blood draws, etc.
- Keywords
- HIV infected mothers, Infants at risk of HIV-infection, Infant lower respiratory tract disease, Infant bloodstream infection
- Medical subject headings
- HIV Infections, Respiratory Tract Diseases, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draws, etc.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
MORTALITY; EPISODES OF SUSPECTED PNEUMONIA; BACTEREMIA; PRESENCE OF NASOPHARYNGEAL VIRAL PATHOGENS; OROPHARYNGEAL COLONIZATION WITH BACTERIAL PATHOGENS
Measured: Between birth and 2 years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2001
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahin Lockman, MD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197691
- Sponsor's protocol ID
- HSC 10027/000BOTS
- Status last verified
- Mar 2012
- First submitted
- 13 Sep 2005
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19090775Shapiro 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.
PubMed 17624842
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botswana Pediatric Respiratory Disease and Bloodstream Infection
- ClinicalTrials.gov ID
- NCT00197691
- Acronym / sponsor ID
- HSC 10027/000BOTS
- Conditions
- HIV Infections, Respiratory Tract Diseases, Sepsis
- Keywords
- HIV infected mothers, Infants at risk of HIV-infection, Infant lower respiratory tract disease, Infant bloodstream infection
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- Mar 2001
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- LIVEBORN INFANT IN THE MASHI PMTCT TRIAL
Key inclusion criteria (1 listed)
- Participation in parent study, "Mashi" HIV vertical transmission prevention study for pregnant Botswana women and their infants
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draws, etc. | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- Derived from this study: PubMed 19090775Shapiro 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.
- Derived from this study: PubMed 17624842Shapiro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahin Lockman, MD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Respiratory Tract Diseases, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE (time frame: Between birth and 2 years of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197691, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.