Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

Malaria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451139
• Other study ID #: AITM0107
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2007
• Last updated: March 22, 2007

Study information

• Verified date: March 2007
• Source: Faculty of Medical Sciences Jimma University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Ethiopia Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• artemether/lumefantrine

• quinine

• atovaquone/proguanil

Locations

Country	Name	City	State
Ethiopia	Jimma University Hospital	Jimma

Sponsors (2)

Lead Sponsor	Collaborator
Faculty of Medical Sciences Jimma University	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Ethiopia,