Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
Information source: Faculty of Medical Sciences Jimma University
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Condition(s) targeted: Malaria
Intervention: artemether/lumefantrine (Drug); quinine (Drug); atovaquone/proguanil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Faculty of Medical Sciences Jimma University Official(s) and/or principal investigator(s):
Nebreed Fesseaha, MD, Dean, Study Chair, Affiliation: Facuty of Medical Sciences Jimma University
Summary
The purpose of the study is to evaluate the potential side-effects of artemether /
lumefantrine and other antimalarials on the auditory function.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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.
Eligibility
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jimma University Hospital, Jimma, Ethiopia
Additional Information
Last updated: March 22, 2007
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