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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Fever 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

ClinicalTrials.gov Identifier:	NCT00386750 History of Changes
Other Study ID Numbers:	CCOA566A2412
Study First Received:	October 11, 2006
Last Updated:	October 11, 2006
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:

Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on February 09, 2012