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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444106
Recruitment Status : Completed
First Posted : March 7, 2007
Results First Posted : March 16, 2011
Last Update Posted : April 5, 2011
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Brief Summary:
To evaluate the potential effects of artemether- lumefantrine on the auditory function

Condition or disease Intervention/treatment Phase
Malaria Falciparum Drug: Artesunate-mefloquine Drug: Atovaquone-proguanil Drug: Artemether-lumefantrine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Artemether-lumefantrine (Coartem)
Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight.
Drug: Artemether-lumefantrine
Other Name: Coartem

Active Comparator: Atovaquone-proguanil (Malarone)
Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight.
Drug: Atovaquone-proguanil
Other Name: Malarone

Active Comparator: Artesunate-mefloquine
Artesunate-mefloquine tablets containing 50 mg artesunate (Plasmotrim) and 250 mg mefloquine (Mephaquin). Artesunate 4 mg/kg/day (for 3 days) and mefloquine 25 mg/kg/day (days 2 and 3) total dose was given once daily dependent upon body weight.
Drug: Artesunate-mefloquine
Other Names:
  • Plasmotrim
  • Mephaquin

Primary Outcome Measures :
  1. 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) [ Time Frame: 7 days ]
    To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An "auditory nerve abnormality" is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups.

Secondary Outcome Measures :
  1. 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) [ Time Frame: Baseline (Day 1), 3, 7, 28 and Day 42 ]
    Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ.

  2. Relationship Between Changes in Auditory Function and Treatment Groups [ Time Frame: From Baseline to Day 7 ]
    ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups.

  3. Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42 [ Time Frame: Days 14, 28 and 42 ]
    Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444106

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Novartis Investigational Site
Tumaco, Colombia
Sponsors and Collaborators
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Study Director: Novartis Novartis
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Responsible Party: Novartis Identifier: NCT00444106    
Other Study ID Numbers: CCOA566A2417
First Posted: March 7, 2007    Key Record Dates
Results First Posted: March 16, 2011
Last Update Posted: April 5, 2011
Last Verified: April 2011
Keywords provided by Novartis:
Plasmodium falciparum
marsh fever
Plasmodium infections
remittent fever
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Artemether, Lumefantrine Drug Combination
Atovaquone, proguanil drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action