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

NCT ID: NCT00386750

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2005-11-30

Brief Summary

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

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

Conditions

Malaria; Falciparum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Artemether-lumefantrine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Other Identifiers

CCOA566A2412

Identifier Type: -

Identifier Source: org_study_id