Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

This study has been completed.
Ludwig-Maximilians - University of Munich
Information provided by:
Faculty of Medical Sciences Jimma University
ClinicalTrials.gov Identifier:
First received: March 21, 2007
Last updated: March 22, 2007
Last verified: March 2007
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Condition Intervention Phase
Drug: artemether/lumefantrine
Drug: quinine
Drug: atovaquone/proguanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Faculty of Medical Sciences Jimma University:

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.

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00451139

Jimma University Hospital
Jimma, Ethiopia
Sponsors and Collaborators
Faculty of Medical Sciences Jimma University
Ludwig-Maximilians - University of Munich
Study Chair: Nebreed Fesseaha, MD, Dean Facuty of Medical Sciences Jimma University
  More Information

ClinicalTrials.gov Identifier: NCT00451139     History of Changes
Other Study ID Numbers: AITM0107 
Study First Received: March 21, 2007
Last Updated: March 22, 2007
Health Authority: Ethiopia: Ethiopia Science and Technology Commission

Additional relevant MeSH terms:
Artemether-lumefantrine combination
Atovaquone, proguanil drug combination
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents

ClinicalTrials.gov processed this record on May 26, 2016