PACTR202201797112873Not yet recruitingPhase 3
A multicentre phase III non-inferiority trial to evaluate safety, tolerability and efficacy of artemether+lumefantrine + atovaquone-proguanil tri-therapy versus artemether+lumefantrine bi-therapy for the treatment of uncomplicated malaria in African children aged 6 to 59 months.
Kwame Nkrumah University of Science and Technology0 sites1,664 target enrollmentStarted: August 11, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 1,664
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 1 Month(s) to 23 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children in the age of 6 to 59 months
- •2.Body weight =5.0kg
- •3.Fever (=37.5°C axillary or 38.0°C oral, rectal or tympanic body temperature) or history of fever in the preceding 24 hours
- •4.Uncomplicated P. falciparum mono-infection with equal or more than 1,000 and less than 200,000 asexual P. falciparum parasites per microliter of blood.
- •5.Signed written informed consent from the child’s legal representative
- •6.Ability to comply with study procedures and follow-up schedules
- •7.Willing to stay in study area during the period of follow-up
- •8.Ability to take oral medication
Exclusion Criteria
- •1.Presence of severe malaria following WHO definition (see Annex 2: WHO definitions for severe falciparum malaria and danger signs)
- •2.Reported intake of any antimalarial drug within the previous 28 days
- •3.Intake of drugs with antimalarial activity or contraindicated drugs within the previous 28 days
- •4.Administration of strong inducers or inhibitors of CYP3A4 such as rifampin, carbamazepine, phenytoin, millepertuis/St. John’s wort/ hypericum perforatum, grapefruit within the previous 28 days
- •5.Known history or evidence of clinically significant medical disorders as determined by the investigator
- •6.Severe malnutrition assessed by middle upper arm circumference (< 115 mm) according to WHO standard
- •7.Screening hemoglobin level <7 g/dL
- •8.Known hypersensitivity or contraindications to any AL and/or AP components
- •9.Known QT prolongation
- •10.Previous participation in a malaria vaccine study
- •11.Participation in the ASAAP study during the previous 42 days
- •12.Participation in other interventional studies within the previous 28 days
- •13.Patients that the investigator considers would be at particular risk if participating in the study
Investigators
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