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

Phase 4TerminatedNCT00386750

Novartis Pharmaceuticals265 enrolled

Overview

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

265

Conditions

Malaria Falciparum

Interventions

Artemether-lumefantrineDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).

Secondary Outcomes

Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)

Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)

Relationship between changes in auditory function and drug exposure.

Data from ClinicalTrials.gov

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