Status:
COMPLETED
Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
Lead Sponsor:
Jimma University
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Conditions:
Malaria
Eligibility:
All Genders
5+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00451139
Last Update
March 23 2007
Active Locations (1)
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1
Jimma University Hospital
Jimma, Ethiopia