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

Tracking Information

First Received Date ^ICMJE

March 6, 2007

Last Updated Date

March 11, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00444106 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Malaria
Falciparum

Intervention ^ICMJE

Drug: artesunate-mefloquine
Drug: atovaquone-proguanil
Drug: Artemether-lumefantrine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

265

Estimated Completion Date

November 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Colombia

Administrative Information

NCT ID ^ICMJE

NCT00444106

Responsible Party

novartis, novartis

Study ID Numbers ^ICMJE

CCOA566A2417

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP