Status:
COMPLETED
Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Malaria in Pregnancy
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
University of Kinshasa
Conditions:
Malaria
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
Malaria in pregnancy is a major cause of maternal and newborn morbidity and mortality in sub-Saharan Africa\]. Effective antimalarial preventive and treatment regimens can significantly reduce malaria...
Detailed Description
The aim of the current trial is to compare the standard 3-day regimen of artemether-lumefantrine to a 5-day regimen of artemether-lumefantrine in a group of pregnant women and a control of non-pregnan...
Eligibility Criteria
Inclusion
- Inclusion criteria for non pregnant women:
- Age ≥18 and ≤ 45 years
- P. falciparum parasitemia ≥ 100 parasites/μL and less than 200.000 parasites/μL
- Hematocrit ≥21%
- Negative HIV test
- Negative pregnancy test\*
- Written informed consent provided
- Willing to stay for 3 or 5 days at the hospital and to comply with the follow-up schedule
- Inclusion criteria for pregnant women (in addition to the above criteria except\*):
- Gestational Age ≥ 14 weeks confirmed by ultrasound
- Singleton viable fetus
- Exclusion criteria for non-pregnant women:
- Severe malaria or signs of severe malaria
- Medical conditions requiring concomitant drug treatment or transfer to a different hospital
- Intake of artemether-lumefantrine within the two previous 2 weeks
- Known allergy to the study drugs
- Previous participation in this study or current participation in other studies
- Exclusion criteria for pregnant women (in addition to the above criteria):
- Signs of labour
- Fetal abnormalities identified by ultrasound
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01916954
Start Date
July 1 2013
Last Update
March 26 2014
Active Locations (1)
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1
University of Kinshasa, Democratic Republic of Congo
Kinshasa, Republic of the Congo