Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

NCT ID: NCT00451139

Last Updated: 2007-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

artemether/lumefantrine

Intervention Type: DRUG

quinine

Intervention Type: DRUG

atovaquone/proguanil

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

Jimma University

OTHER

Sponsor Role: lead

Principal Investigators

Nebreed Fesseaha, MD, Dean

Role: STUDY_CHAIR

Facuty of Medical Sciences Jimma University

Locations

Jimma University Hospital

Jimma, , Ethiopia

Countries

Ethiopia

Other Identifiers

AITM0107

Identifier Type: -

Identifier Source: org_study_id