Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

Jimma University

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: artemether/lumefantrine; Drug: atovaquone/proguanil; Drug: quinine

Study type: Interventional

Funder types: Other

Identifiers

NCT00451139

AITM0107

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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