Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

A) for the treatment of uncomplicated malaria during second and third trimester pregnancy to oral Quinine hydrochloride. The PCR-corrected adequate clinical and parasitological response (ACPR) on day 42 is considered as the primary efficacy criterion. Newborns will be followed for growth and development indicators.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epicentre
• Collaborators: Medecins Sans Frontieres, Netherlands; Shoklo Malaria Research Unit; Sholklo Malaria Research Unit; University of Cape Town
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine; Quinine

Criteria

Inclusion Criteria:

Cohort Study:

• Weeks of pregnancy between 13 and 22 weeks

• Resident in Mbarara Municipality (radius of 15km from MNRH)

• Cohort study signed informed consent form

Efficacy Study:

• Pregnant woman

• Malaria infection, detected by microscopy, with P. falciparum (mixed or mono-infection)

• Age of gestation: 13 weeks and beyond

• Efficacy study signed informed consent form

Exclusion Criteria:

Efficacy Study:

• P. falciparum parasitaemia above 250,000 parasites/μl

• Severe anaemia

• Signs or symptoms of severe/complicated malaria requiring parenteral treatment (WHO 2000)

• Known allergy to artemisinin derivatives, lumefantrine or quinine;

• Previous participation in the efficacy study

• Inability to attend the efficacy study follow-up schedule.