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Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00451139
First Posted: March 23, 2007
Last Update Posted: March 23, 2007
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.
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
Jimma University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by 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

Information from the National Library of Medicine

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


Locations
Ethiopia
Jimma University Hospital
Jimma, Ethiopia
Sponsors and Collaborators
Jimma University
Ludwig-Maximilians - University of Munich
Investigators
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
First Submitted: March 21, 2007
First Posted: March 23, 2007
Last Update Posted: March 23, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Lumefantrine
Artemether
Quinine
Atovaquone
Proguanil
Artemether-lumefantrine combination
Artemisinins
Atovaquone, proguanil drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites