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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria; Falciparum

Intervention: Artesunate-mefloquine (Drug); Atovaquone-proguanil (Drug); Artemether-lumefantrine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis


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

Clinical Details

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

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

Primary outcome: Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)

Secondary outcome:

Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)

Relationship Between Changes in Auditory Function and Treatment Groups

Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

- 12 years of age or older

- Accepts Healthy Volunteers

- 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


- 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.

Locations and Contacts

Novartis Investigational Site, Tumaco, Colombia
Additional Information

Starting date: May 2007
Last updated: April 1, 2011

Page last updated: August 23, 2015

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