Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function

• Status: Terminated
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

To evaluate the effects of artemether/ lumefantrine on the auditory function.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

Criteria

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.)