Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

This study has been completed.
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
Faculty of Medical Sciences Jimma University
ClinicalTrials.gov Identifier:
NCT00451139
First received: March 21, 2007
Last updated: March 22, 2007
Last verified: March 2007

March 21, 2007
March 22, 2007
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Complete list of historical versions of study NCT00451139 on ClinicalTrials.gov Archive Site
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Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
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The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Malaria
  • Drug: artemether/lumefantrine
  • Drug: quinine
  • Drug: atovaquone/proguanil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
5 Years and older
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Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT00451139
AITM0107
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Faculty of Medical Sciences Jimma University
Ludwig-Maximilians - University of Munich
Study Chair: Nebreed Fesseaha, MD, Dean Facuty of Medical Sciences Jimma University
Faculty of Medical Sciences Jimma University
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP