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Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

2014-07-24 14:21:58 | BioPortfolio

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.

Study Design

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

Conditions

Malaria

Intervention

artemether/lumefantrine, quinine, atovaquone/proguanil

Location

Jimma University Hospital
Jimma
Ethiopia

Status

Completed

Source

Faculty of Medical Sciences Jimma University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:21:58-0400

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Medical and Biotech [MESH] Definitions

A biguanide compound which has little antimalarial activity until metabolized in the body to the active antimalarial agent cycloguanil. The usefulness of proguanil is limited by the rapid development of drug resistance by the malarial parasite. The hydrochloride is used for the casual prophylaxis of falciparum malaria, to suppress other forms of malaria, and to reduce transmission of infection (From Martindale, The Extra Pharmacopoeia, 30th ed, p405)

A biguanide compound which metabolizes in the body to form cycloguanil, an anti-malaria agent.

A genus of rubiaceous South American trees that yields the toxic CINCHONA ALKALOIDS from their bark; QUININE; QUINIDINE; chinconine, cinchonidine and others are used to treat malaria and cardiac arrhythmias.

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