Efficacy, safety and population pharmacokinetics of artesunate-mefloquine combination for the treatment of uncomplicated falciparum malaria in African children versus artemether-lumefantrine

Phase 4

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN17472707
• Lead Sponsor: Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-26
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 940

Inclusion Criteria

1. Aged between 6 to 59 months, either sex
2. Presence of acute uncomplicated P. falciparum mono-infection confirmed by:
2.1. Axillary temperature greater than 37.5°C, and
2.2. Positive microscopy of P. falciparum with parasite density between 2,000 and 200,000 asexual parasites/µl
3. Written informed consent from parent/guardian

Exclusion Criteria

1. Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000
2. Weight less than 5 kg
3. Inability to tolerate oral medication (presence of any of the following danger signs: unable to drink or breastfeed, severe vomiting, recent history of convulsions, lethargic or unconscious state, unable to sit or stand up)
4. Mixed Plasmodium infection
5. Presence of febrile conditions caused by diseases other than malaria
6. Known history of hypersensitivity, allergic or serious adverse reactions to mefloquine, quinine, quinidine, artesunate or other artemisinins
7. History of use of any anti-malarial agent within 2 weeks prior to start of the study (except mefloquine and piperaquine within 4 weeks)
8. Prior participation in a therapeutic trial within 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified