NCT00451139

Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: Jimma University · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: —

Summary

The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Detailed description

Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	artemether/lumefantrine
DRUG	quinine
DRUG	atovaquone/proguanil

Timeline

• First posted: 2007-03-23
• Last updated: 2007-03-23

Locations

1 site across 1 country: Ethiopia