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

Information source: Novartis
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria; Falciparum

Intervention: artesunate-mefloquine (Drug); atovaquone-proguanil (Drug); Artemether-lumefantrine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Overall contact:
novartis, Phone: 41613241111


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

Clinical Details

Official title: An Open-Label, Randomized, Single-Center, Parallel Group Study of the Effects of Artemether-Lumefantrine (Coartem®) Atovaquone-Proguanil (Malarone®) and Artesunate-Mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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 other antimalarial agents assessed by pure tone thresholds assessments (a type of hearing test)

Relationship between changes in auditory function and drug exposure


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria 12 years of age or older 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.

Locations and Contacts

novartis, Phone: 41613241111

Novartis Investigational Site, Tumaco, Colombia; Recruiting
Additional Information

Starting date: June 2007
Ending date: November 2008
Last updated: July 2, 2008

Page last updated: August 08, 2008

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