Phase 4 N=265 Randomized Treatment

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

Malaria · Falciparum

Bottom Line

View on ClinicalTrials.gov: NCT00444106 ↗

Enrolled (actual)

265

Serious AEs

0.4%

Results posted

Mar 2011

Primary outcome: Primary: 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) — 2.6 Percentage of Participants — p=<.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Artesunate-mefloquine (Drug); Atovaquone-proguanil (Drug); Artemether-lumefantrine (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	2.6	<.0001 sig
SECONDARY 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)	12.2; 12.0; 12.7; -2.5; -2.4; -1.9	—
SECONDARY Relationship Between Changes in Auditory Function and Treatment Groups	3.86; 3.89; 3.86; 0.01; -0.01; -0.04	—
SECONDARY Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42	99.4; 100.0; 98.1; 98.7; 98.1; 98.1	—

Summary

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

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00444106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.