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Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

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ClinicalTrials.gov Identifier: NCT00451139
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : March 23, 2007
Ludwig-Maximilians - University of Munich
Information provided by:
Jimma University

Brief Summary:
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Condition or disease Intervention/treatment Phase
Malaria Drug: artemether/lumefantrine Drug: quinine Drug: atovaquone/proguanil Phase 4

Detailed Description:
Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients aged above 5 years
  • Uncomplicated falciparum malaria
  • Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
  • Ability to tolerate oral therapy
  • Informed consent by the patient or by parent/guardian for children
  • Residence in study area

Exclusion Criteria:

  • Known or suspected hearing deficits
  • Adequate anti-malarial treatment within the previous 7 days
  • Mixed infection
  • Danger signs and signs of severe malaria as defined by the WHO
  • Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
  • Concomitant disease masking assessment of response
  • History of allergy or intolerance against study medications
  • Pregnancy

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): NCT00451139

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Jimma University Hospital
Jimma, Ethiopia
Sponsors and Collaborators
Jimma University
Ludwig-Maximilians - University of Munich
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Study Chair: Nebreed Fesseaha, MD, Dean Facuty of Medical Sciences Jimma University
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ClinicalTrials.gov Identifier: NCT00451139    
Other Study ID Numbers: AITM0107
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: March 23, 2007
Last Verified: March 2007
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Artemether, Lumefantrine Drug Combination
Atovaquone, proguanil drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Sensory System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action