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

Novartis

Status and phase: Terminated; Phase 4

Conditions: Falciparum; Malaria

Treatments: Drug: Artemether-lumefantrine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386750

CCOA566A2412

Details and patient eligibility

About

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

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

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)