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
Sponsor study identifier
interventional
265
1 country
1
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)To evaluate the potential effects of artemether- lumefantrine on the auditory function
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2007
Actual (reported)March 7, 2007
Actual (reported)May 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 2008
Actual (reported)November 2008
Actual (reported)March 16, 2011
Actual (reported)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)
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.
7 days
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)
Baseline (Day 1), 3, 7, 28 and Day 42
Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight.
Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight.
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.
Novartis Investigational Site
Tumaco, Colombia
Novartis
Novartis
265 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2007
First Posted
March 7, 2007
Study Start
May 2007
Date type not reportedThis date has not been verified as actual or estimated.
Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso
Relationship Between Changes in Auditory Function and Treatment Groups
From Baseline to Day 7
Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42
Days 14, 28 and 42
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Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)Last Updated
April 5, 2011
Results First Posted
March 16, 2011
Record last verified: 2011-04
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Source: ClinicalTrials.gov.
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