Artesunate Plus Sulfadoxine-pyrimethamine Pharmacokinetics, Efficacy, Gametocytes Carriage and Birth Outcomes in Pregnant Women With Malaria

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

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 other studies. In addition the efficacy and safety of the study drugs will be determined for pregnant women and their babies.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Karen I Barnes
• Collaborators: Global Fund; Medical Research Council, South Africa
• Treatments: Artemisinins; Artesunate; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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