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

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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386750

Enrollment

265

Registered

2006-10-12

Start date

2005-06-30

Completion date

2005-11-30

Last updated

2012-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falciparum, Malaria

Keywords

Malaria, hearing, co-artemether, auditory, Plasmodium falciparum, marsh fever, Plasmodium infections, remittent fever, paludism, artemether, artemisinins, benflumetol, lumefantrine

Brief summary

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function.

Interventions

DRUGArtemether-lumefantrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026