Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00386750

Purpose

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

To evaluate the effects of artemether/ lumefantrine on the auditory function.

Condition	Intervention	Phase
Malaria Falciparum	Drug: Artemether-lumefantrine	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Artemether Benflumetol Co-artemether

U.S. FDA Resources

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 a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)
Relationship between changes in auditory function and drug exposure.

Estimated Enrollment:	265
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

12 years of age or older
P. falciparum parasitemia between 50 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

(Other protocol-defined inclusion/exclusion criteria may apply.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386750

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CCOA566A2412
Study First Received:	October 11, 2006
Last Updated:	October 11, 2006
ClinicalTrials.gov Identifier:	NCT00386750 History of Changes
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Novartis:

Malaria
hearing
co-artemether
auditory
Plasmodium falciparum
marsh fever
Plasmodium infections

remittent fever
paludism
artemether
artemisinins
benflumetol
lumefantrine

Additional relevant MeSH terms:

Benflumetol
Protozoan Infections
Anti-Infective Agents
Antiprotozoal Agents
Antiplatyhelmintic Agents
Coccidiosis
Anthelmintics
Malaria
Schistosomicides

Pharmacologic Actions
Malaria, Falciparum
Artemether
Antimalarials
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Parasitic Diseases
Coccidiostats

ClinicalTrials.gov processed this record on November 27, 2009