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

Malaria Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00386750
• Other study ID #: CCOA566A2412
• Status: Terminated
• Phase: Phase 4
• First received: October 11, 2006
• Last updated: April 25, 2012
• Start date: June 2005
• Est. completion date: November 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 265
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.)

Study Design

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

Related Conditions & MeSH terms

• Falciparum
• Malaria

Intervention

Drug:
• Artemether-lumefantrine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).
Secondary	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)
Secondary	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)
Secondary	Relationship between changes in auditory function and drug exposure.