Therapeutic Efficacy Study of AL and DP in Western Kenya

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Artemether-lumefantrine (AL) was adopted as first-line antimalarial therapy in Kenya in 2006, and dihydroartemisinin-piperaquine (DP) as the second-line therapy in 2010. In order to monitor the efficacy and potential development of resistance of Plasmodium falciparum parasites to these two drugs, we will conduct an in-vivo study to monitor the efficacy of these antimalarial therapies.

A standardized World Health Organization (WHO) in-vivo efficacy study will be conducted in western Kenya among children 6-59 months of age with symptomatic, uncomplicated malaria visiting the out-patient department of hospitals and/or clinics in western Kenya.

In this study, 350 children will be randomly assigned to be treated with either AL or DP. Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period. Molecular analysis will be conducted to determine the frequency of markers of antimalarial resistance, and to differentiate recrudescence from reinfection. Results from this antimalarial drug efficacy study will be used to assist the Kenya national malaria control program (NMCP) in evaluating the national malaria treatment policy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kenya Medical Research Institute
• Collaborator: Centers for Disease Control and Prevention
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Artenimol; Lumefantrine; Piperaquine

Criteria

Inclusion Criteria:

1. Age 6-59 months

2. Weight ≥ 5.0 kg

3. Axillary temperature ≥ 37.5C or history of fever in the past 24 hours

4. Hemoglobin ≥7 grams/deciliter at enrolment

5. Slide-confirmed mono-infection with Plasmodium falciparum and asexual parasite density between 2,000-200,000 parasites/μl

6. Live within the catchment boundaries of the study site (10km radius)

7. Able to swallow oral medication

8. Able and willing to comply with the protocol for the duration of the study

9. Able and willing to comply with the study visit schedule on days 2, 3, 7, 14, 21, 28, 35, and 42

10. Parent or caregiver has access to a phone and agrees to have study staff contact them for visit reminders during study period

11. Written informed consent provided by parent/guardian

Exclusion Criteria:

1. Presence of severe malaria or danger signs, including prostration, alteration in level of consciousness, respiratory distress, convulsions, or jaundice

2. Severe malnutrition according to WHO child growth standards (weight for age <3 standard deviations)

3. Known hypersensitivity to AL or DP

4. Use of antimalarials or other drugs with antimalarial activity in the last 2 weeks

5. General clinical condition necessitates hospitalization

6. Evidence of concomitant infections at the time of presentation

7. Plan to travel or leave the area within the next 3 months

8. Previously enrolled in this study