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Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

Information source: Faculty of Medical Sciences Jimma University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria

Intervention: artemether/lumefantrine (Drug); quinine (Drug); atovaquone/proguanil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Faculty of Medical Sciences Jimma University

Official(s) and/or principal investigator(s):
Nebreed Fesseaha, MD, Dean, Study Chair, Affiliation: Facuty of Medical Sciences Jimma University

Summary

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

Clinical Details

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

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

Minimum age: 5 Years. Maximum age: N/A. Gender(s): 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

Locations and Contacts

Jimma University Hospital, Jimma, Ethiopia
Additional Information


Last updated: March 22, 2007

Page last updated: August 23, 2015

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