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
  Purpose

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
Malaria
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
Artemether-lumefantrine combination
Artemisinins
Atovaquone, proguanil drug combination
Lumefantrine
Anthelmintics
Anti-Infective Agents
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Coccidiostats
Pharmacologic Actions
Schistosomicides
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014