Malaria
Conditions
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.
Interventions
Sponsors
Ludwig-Maximilians - University of Munich
Jimma University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
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
Countries
Ethiopia
Outcome results
None listed