Antimalrials tri-therapy with atovaquone-proguanil for treatment of uncomplicated malaria in African childre

Phase 3

• Conditions: Malaria

• Registration Number: PACTR202201797112873
• Lead Sponsor: Kwame Nkrumah University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1664

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified