Monitoring the efficacy of mefloquine-artesunate combinatio

Phase 4

Completed

• Conditions: Drug resistant Plasmodium falciparum malariaArtemisinin resistanceK- 13 mutation in Plasmodium falciparum malariaPfmdr1(Plasmodium falciparum multi drug resistant gene 1) copy number variation; Mefloquine and artesunate combination; Thai Myanmar border; Drug resistant Plasmodium falciparum malaria; Artemisinin resistance; K- 13 mutation in Plasmodium falciparum malaria; Pfmdr1

• Registration Number: TCTR20150623001
• Lead Sponsor: ot available

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-12-27
• Study Start: 2015-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1022

Inclusion Criteria

•Non pregnant patients of any age and sex who received treatment for uncomplicated malaria between January 2003 to December 2013
•Symptomatic of malaria infection, i.e. history of fever or tympanic temperature ≥37.5°c
•Microscopically confirmed asexual stages of P. falciparum ≥ 5/500 WBC (alone or mixed with non- P. falciparum species)
•Received fully supervised treatment of mefloquine-artesunate

Exclusion Criteria

•Pregnant woman
•P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175 000/µL).
•Signs or symptoms indicative of severe malaria:
•Mefloquine treatment within 60 days of current episode of malaria
•Splenectomy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Day-42 PCR adjusted cure rate 42 days Asexual parasitaemia by microscopy

Secondary Outcome Measures

Name	Time	Method
Day-3 positivite for asexual parasitaemia day-3 Asexual parasitaemia by microscopy