Status:
COMPLETED
"Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in Bagamoyo District, Tanzania"
Lead Sponsor:
Muhimbili University of Health and Allied Sciences
Collaborating Sponsors:
Uppsala University
Karolinska Institutet
Conditions:
Malaria,Falciparum
Eligibility:
All Genders
1-65 years
Phase:
PHASE4
Brief Summary
This clinical trial evaluates the advantage of prolonging the therapeutic life span of Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine 0.25mg/kg. The study...
Detailed Description
Despite documented high cure rates of ACT in Tanzania, and Africa elsewhere, clinical trials conducted in Tanzania with Swedish International Development cooperation Agency (SIDA) and Swedish Research...
Eligibility Criteria
Inclusion
- Age more than 1 year and less than 65 years.
- Weight 10 kg and above;
- Body temperature ≥37.5°C or history of fever in the last 24 hours;
- Microscopy determined asexual P. falciparum mono-infection regardless of parasitemia
- Normal - corrected QT Interval in Baseline ECG of less than 440ms in male and 460ms in females
Exclusion
- Symptoms/signs of severe malaria or danger signs;
- Pregnancy, Breastfeeding or unwilling to practice birth control during participation in the study.
- Known allergy to study medications;
- Hb \<8 g/dl;
- Reported antimalarial intake within last 2 weeks;
- On regular medication, which may interfere with antimalarial pharmacokinetics and
- Blood transfusion within last 90 days.
Key Trial Info
Start Date :
July 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2018
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03241901
Start Date
July 27 2017
End Date
February 17 2018
Last Update
March 27 2018
Active Locations (2)
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1
Fukayosi Dispensary
Bagamoyo, Coast Region, Tanzania, +255
2
Yombo Dispensary
Bagamoyo, Yombo, Tanzania, +255