Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the potential effects of artemether- lumefantrine on the auditory function

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Atovaquone; Atovaquone, proguanil drug combination; Lumefantrine; Mefloquine; Proguanil

Criteria

Inclusion Criteria

• 12 years of age or older

• Accepts Healthy Volunteers

• P. falciparum parasitemia between 1,000 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

• Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age)

Other protocol-defined inclusion/exclusion criteria may apply.