Validation of New Biomarkers for Monitoring P. falciparum Reduced susceptibility/Tolerance or Resistance to Artemisinin Derivatives and Partner Drugs

Not Applicable

• Conditions: Malaria

• Registration Number: PACTR201508001191898
• Lead Sponsor: EDCTP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Symptoms compatible with acute uncomplicated malaria with pure Plasmodium falciparum parasitemia.
Microscopically confirmed P. falciparum infection with parasite density ¿ 2,000/¿l of blood
Body (axillary) temperature > 37.4oC or history of fever 24 ¿ 48 hours preceding presentation.
No have other concomitant illness.
No history of antimalarial use in the two weeks preceding presentation.
Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule.
Written informed consent given by parents or guardians.

Exclusion Criteria

Severe malaria
Severe malnutrition.
Serious underlying disease (renal, cardiac, hepatic)
Concomitant febrile illness.
Known allergy to study drug or its components.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome (cured or treatment failures)

Secondary Outcome Measures

Name	Time	Method
Parasites reduction ratio;Parasites and fever clearance times;Blood drugs levels;in vitro susceptibility profiles of parasites from patient isolates;Mutations/haplotypes in transporter Plasmodium falciparum transporter genes