Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy (NCT01054248) | Clinical Trial Compass
CompletedPhase 3
Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy
Thailand511 participantsStarted 2010-02-16
Plain-language summary
This is a randomised, open label trial, comparing standard dose of dihydroartemisinin-piperaquine (DP) with standard fixed artesunate-mefloquine regimen (MAS3) and with a longer regimen of artemether-lumefantrine (ALN+) in the treatment of uncomplicated malaria in pregnant women. The sample size is 335 women in each arm which would be 1005 women in total. Pregnant patients in 2nd and 3rd trimester with acute uncomplicated malaria who meet eligibility criteria will be asked to participate in the study. The primary objective is to determine if the efficacy of DP and MAS3 are superior to ALN+ in the treatment of uncomplicated malaria in pregnancy. The study will also incorporate a dense pharmacokinetic study of mefloquine and artesunate (15 women in the MAS3 arm) and a population pharmacokinetic study for mefloquine, piperaquine and lumefantrine.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
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:
* Age 18-45 years
* Viable pregnancy of any gestation as assessed by ultrasound scanning
* Microscopically confirmed uncomplicated malaria (parasitaemia ≥ 5/500 WBC) with Plasmodium falciparum or Mixed infection (i.e. P.falciparum \& P.vivax/ovale/malariae) or Plasmodium vivax/ovale/malariae
* Willingness and ability to comply with the study protocol for the duration of the trial
* Written informed consent provided
* No signs of labour
Additional criteria for patients in the detailed pharmacokinetic study group (N=24 in the MAS3 arm):
* HCT\>25% (based on field reading i.e. capillary sample)
* P.falciparum monoinfection
* Agree to stay in the clinic for 7 days
* Written consent to participate the detailed PK subgroup
Exclusion Criteria:
* Known hypersensitivity to the study drugs
* P.falciparum asexual stage parasitaemia ≥ 4% RBCs
* Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1
* Gastrointestinal dysfunction that could alter absorption or motility
* History or known liver diseases or other chronic diseases (excluding thalassemia \& G6PD deficiency)
* Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study
* Splenectomy
* Hematocrit (HCT) \<20% (based on field reading i.e. capillary sample) \[ \*NB: Dense mefloquine pharmacokinetic exclusion if HCT \< 25%\]
* Taking contraindicated medications
* Hist…
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
1
Cure rate defined as clearance of asexual parasites without recurrence within the period between treatment and delivery or a 63 day period
Timeframe: Day 63 or until delivery, whichever occurs later