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