Trial | NCT00451139  Report issue

Title

Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.
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 Started
Mar 21
2007
Last Update
Mar 23
2007
Estimate

Drug artemether/lumefantrine

Drug quinine

Drug atovaquone/proguanil

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
No Results Posted