Evaluation of the efficacy of Artemisinin Combination therapy in Kenya

Phase 4

Conditions: Malaria

Registration Number: PACTR202404710340979

Lead Sponsor: Kenya Medical Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 330

Inclusion Criteria

•age between 6 Months to 14 years
•mono infection with P. falciparum confirmed by positive blood smear (i.e., no mixed infection).
•parasitaemia of parasitaemia between 1,000 – 200,000 p/µl
•presence of axillary or tympanic temperature = 37.5 °C or fever history during the past 24 h.
•ability to swallow oral medication.
•ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule.
•informed consent from a parent or guardian and an informed assent from any minor participant aged from 12 to 14 years

Exclusion Criteria

•presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1)
•weight under 5 kg.
•haemoglobin < 5 g/dl
•mixed or mono infection with another Plasmodium species detected by microscopy.
•presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score,
•presence of febrile conditions due to diseases other than malaria (e.g., measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g., cardiac, renal and hepatic diseases, HIV/AIDS)
•regular medication, which may interfere with antimalarial pharmacokinetics.
•history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
•a positive pregnancy test or breastfeeding; and
•unable to or unwilling to take pregnancy test or to use contraception for girls of child-bearing age (defined as age > 12 years and sexually active)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adequate clinical Parasitological Response

Secondary Outcome Measures

Name	Time	Method
1. Highlight the prevalence of Pfk13 antimalarial drug resistance marker.<br>2. Determine the use of the novel marker, Pfcoronin, as an indication for antimalarial drug resistance