CompletedPhase 4

Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy

Uganda300 participantsStarted 2006-10

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42 or at delivery.

Timeframe: 3 years

Trial details

NCT IDNCT00495508

SponsorEpicentre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-06

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