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

Novartis

Status and phase: Completed; Phase 4

Conditions: Falciparum; Malaria

Treatments: Drug: Artemether-lumefantrine; Drug: Artesunate-mefloquine; Drug: Atovaquone-proguanil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444106

CCOA566A2417

Details and patient eligibility

About

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

Enrollment: 265 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 3 patient groups

Artemether-lumefantrine (Coartem)

Experimental group

Description:

Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight.

Treatment:

Drug: Artemether-lumefantrine

Atovaquone-proguanil (Malarone)

Active Comparator group

Description:

Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight.

Treatment:

Drug: Atovaquone-proguanil

Artesunate-mefloquine

Active Comparator group

Description:

Artesunate-mefloquine tablets containing 50 mg artesunate (Plasmotrim) and 250 mg mefloquine (Mephaquin). Artesunate 4 mg/kg/day (for 3 days) and mefloquine 25 mg/kg/day (days 2 and 3) total dose was given once daily dependent upon body weight.

Treatment:

Drug: Artesunate-mefloquine