Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria; Falciparum
Intervention: Artemether-lumefantrine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis
Summary
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.
To evaluate the effects of artemether/ lumefantrine on the auditory function.
Clinical Details
Official title: An Open-Label, Single-Center Study of the Effects of co-Artemether, Atovaquone-Proguanil, 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 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.
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 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.)
Locations and Contacts
Additional Information
Starting date: June 2005
Last updated: October 11, 2006
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