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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00386750
Recruitment Status : Terminated
First Posted : October 12, 2006
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:


To evaluate the effects of artemether/ lumefantrine on the auditory function.

Condition or disease Intervention/treatment Phase
Malaria Falciparum Drug: Artemether-lumefantrine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2005
Primary Completion Date : November 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. 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)
  2. 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)
  3. Relationship between changes in auditory function and drug exposure.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386750

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00386750     History of Changes
Other Study ID Numbers: CCOA566A2412
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Plasmodium falciparum
marsh fever
Plasmodium infections
remittent fever

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents