Status:
COMPLETED
Pharmacokinetics, Efficacy, Gametocyte Carriage, Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment in Pregnant Women
Lead Sponsor:
Professor Karen I Barnes
Collaborating Sponsors:
Global Fund
Medical Research Council, South Africa
Conditions:
Malaria
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine found when given to pregnant women for the prevention of malaria to those found in pregnant women given the sa...
Detailed Description
Pregnancy increases the risk of malaria progression and complications with up to a 10-fold increase in the malaria case fatality rate in areas of low transmission. Sulfadoxine-pyrimethamine (SP) is us...
Eligibility Criteria
Inclusion
- Pregnant female, older than 18 years, \> 35kg.
- Gestational age \> 16 weeks (fundal height \> 16cm) and below 36 weeks gestation.
- Documented informed consent.
- Lives close enough to the study site for reliable follow up and is willing to attend ANC and follow-up visits regularly.
Exclusion
- Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia
- Has received anti-malarial treatment in the past 7 days and/or sulfadoxine-pyrimethamine in the past 28 days.
- Known hepatic or renal impairment
- Has received chloramphenicol, cotrimoxazole or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
- History of G6PD deficiency.
- Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole).
- Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
- Imminent delivery expected.
- Prior inclusion in this study.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00380146
Start Date
September 1 2006
End Date
March 1 2008
Last Update
October 26 2016
Active Locations (1)
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1
Ndlavela Health Centre
Ndlavela, Maputo, Mozambique