Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

Phase 4

Completed

• Conditions: Malaria

• Registration Number: NCT00451139
• Lead Sponsor: Jimma University

Brief 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.

Study Timeline

• Status Verified: 2007-03
• Study First Submitted: 2007-03-21
• Study First Submitted QC: 2007-03-22
• Last Update Submitted: 2007-03-22
• Study First Posted: 2007-03-23
• Last Update Posted: 2007-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients aged above 5 years
• Uncomplicated falciparum malaria
• Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
• Ability to tolerate oral therapy
• Informed consent by the patient or by parent/guardian for children
• Residence in study area

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Exclusion Criteria

• Known or suspected hearing deficits
• Adequate anti-malarial treatment within the previous 7 days
• Mixed infection
• Danger signs and signs of severe malaria as defined by the WHO
• Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
• Concomitant disease masking assessment of response
• History of allergy or intolerance against study medications
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Jimma University Hospital; 🇪🇹 Jimma, Ethiopia