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

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Malaria trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

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