Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4

Details

• Lead Sponsor: Jimma University
• Collaborator: Ludwig-Maximilians - University of Munich
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Atovaquone; Atovaquone, proguanil drug combination; Lumefantrine; Proguanil; Quinine

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