Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00444106

Purpose

To evaluate the potential effects of artemether- lumefantrine on the auditory function

Condition	Intervention	Phase
Malaria Falciparum	Drug: artesunate-mefloquine Drug: atovaquone-proguanil Drug: Artemether-lumefantrine	Phase IV

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate Artemisinin Artemether Benflumetol Atovaquone Chloroguanide Mefloquine Mefloquine hydrochloride Malarone Co-artemether

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomized, Single-Center, Parallel Group Study of the Effects of Artemether-Lumefantrine (Coartem®) Atovaquone-Proguanil (Malarone®) and Artesunate-Mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older

Further study details as provided by Novartis:

Primary Outcome Measures:

Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).

Secondary Outcome Measures:

Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)
Changes in auditory function with other antimalarial agents assessed by pure tone thresholds assessments (a type of hearing test)
Relationship between changes in auditory function and drug exposure

Enrollment:	265
Study Start Date:	June 2007
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Experimental	Drug: Artemether-lumefantrine Artemether-lumefantrine
2: Active Comparator	Drug: atovaquone-proguanil
3: Active Comparator	Drug: artesunate-mefloquine

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria 12 years of age or older P. falciparum parasitemia between 1,000 and 100,000 parasites/μl History of fever or presence of fever (temperature ≥ 37.5°C)

Exclusion Criteria Signs/symptoms of severe/complicated malaria Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months History of any drug-related hearing impairment. Abnormal hearing function at study entry Exposure to sustained loud noises, by self-report, within the past 24 hours. Present ear problems Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age) Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444106

Locations

Colombia
Novartis Investigational Site
Tumaco, Colombia

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	novartis ( novartis )
Study ID Numbers:	CCOA566A2417
Study First Received:	March 6, 2007
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00444106
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:

Malaria
hearing
coartemether
auditory
Plasmodium falciparum
marsh fever
Plasmodium infections

remittent fever
paludism
artemether
artemisinins
benflumetol
lumefantrine

Study placed in the following topic categories:

Artesunate
Benflumetol
Protozoan Infections
Artemether-lumefantrine combination
Malarone
Clotrimazole
Miconazole
Artemisinine
Tioconazole

Malaria
Malaria, Falciparum
Artemether
Fever
Artemisinins
Atovaquone
Chloroguanide
Parasitic Diseases
Mefloquine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis
Antiplatyhelmintic Agents
Enzyme Inhibitors
Anthelmintics

Schistosomicides
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Amebicides
Coccidiostats

ClinicalTrials.gov processed this record on January 16, 2009