Status:
TERMINATED
Artesunate Plus Sulfadoxine-pyrimethamine Pharmacokinetics, Efficacy, Gametocytes Carriage and Birth Outcomes in Pregnant Women With Malaria
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 artesunate and sulfadoxine-pyrimethamine found in pregnant women with malaria to those drug levels found in non-pregnant women from othe...
Detailed Description
The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria, and this poses a particular problem for the treatment of pregnant women, a group espec...
Eligibility Criteria
Inclusion
- Pregnant female, older than 18 years, \> 35kg.
- Gestational age \> 16 weeks (fundal height \> 16cm) and below 36 weeks gestation.
- Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 250 000 asexual parasites/ul blood with axillary temperature of greater than or equal to 37.5°C or history of fever (defined as fever within the previous 24 hours).
- Documented written informed consent.
- Lives close enough to the study site for reliable follow up and is willing to attend ANC and follow-up visits regularly.
- Is willing to stop taking folate for 7 days if applicable.
Exclusion
- Has received anti-malarial treatment in the past 7 days.
- Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated) or other danger signs (Appendix 2).
- Known hepatic or renal impairment
- Has received chloramphenicol 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, or other artemisinin derivatives e.g. co-artemether).
- 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 :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00331708
Start Date
April 1 2006
End Date
July 1 2007
Last Update
October 26 2016
Active Locations (1)
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1
Ndlavela Health Centre
Ndlavela, Maputo, Mozambique