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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria; Falciparum

Intervention: Artemether-lumefantrine (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

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


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


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


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


- 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: April 25, 2012

Page last updated: August 23, 2015

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