Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

This study has been completed.

Sponsors and Collaborators:	Faculty of Medical Sciences Jimma University Ludwig-Maximilians - University of Munich
Information provided by:	Faculty of Medical Sciences Jimma University
ClinicalTrials.gov Identifier:	NCT00451139

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 IV

MedlinePlus related topics: Malaria

Drug Information available for: Artemether Benflumetol Atovaquone Quinine Quinine bisulfate Quinine hydrochloride Quinine sulfate Chloroguanide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Study placed in the following topic categories:

Benflumetol
Artemether-lumefantrine combination
Malarone
Atovaquone
Clotrimazole
Quinine

Miconazole
Tioconazole
Chloroguanide
Malaria
Artemether

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antiplatyhelmintic Agents
Anthelmintics
Enzyme Inhibitors
Schistosomicides

Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Coccidiostats

ClinicalTrials.gov processed this record on January 14, 2009