- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451139
Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
March 22, 2007 updated by: Jimma University
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jimma, Ethiopia
- Jimma University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Nebreed Fesseaha, MD, Dean, Facuty of Medical Sciences Jimma University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
March 21, 2007
First Submitted That Met QC Criteria
March 22, 2007
First Posted (Estimate)
March 23, 2007
Study Record Updates
Last Update Posted (Estimate)
March 23, 2007
Last Update Submitted That Met QC Criteria
March 22, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antimetabolites
- Antiprotozoal Agents
- Antiparasitic Agents
- Neuromuscular Agents
- Antimalarials
- Muscle Relaxants, Central
- Atovaquone
- Proguanil
- Lumefantrine
- Artemether
- Artemether, Lumefantrine Drug Combination
- Quinine
- Atovaquone, proguanil drug combination
Other Study ID Numbers
- AITM0107
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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