Status:
TERMINATED
Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Malaria
Falciparum
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 12 years of age or older
- P. falciparum parasitemia between 50 and 100,000 parasites/μl
- History of fever or presence of fever (temperature ≥ 37.5°C)
- Exclusion Criteria
- Signs/symptoms of severe/complicated malaria
- Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
- History of any drug-related hearing impairment.
- Abnormal hearing function at study entry
- Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems
- (Other protocol-defined inclusion/exclusion criteria may apply.)
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00386750
Start Date
June 1 2005
End Date
November 1 2005
Last Update
April 27 2012
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