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

Primary Purpose

Malaria, Falciparum

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Artemether-lumefantrine
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malaria, hearing, co-artemether, auditory, Plasmodium falciparum, marsh fever, Plasmodium infections, remittent fever, paludism, artemether, artemisinins, benflumetol, lumefantrine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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/exclusion criteria may apply.)

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    October 11, 2006
    Last Updated
    April 25, 2012
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00386750
    Brief Title
    Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Terminated
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    November 2005 (Actual)
    Study Completion Date
    November 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria, Falciparum
    Keywords
    Malaria, hearing, co-artemether, auditory, Plasmodium falciparum, marsh fever, Plasmodium infections, remittent fever, paludism, artemether, artemisinins, benflumetol, lumefantrine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    265 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Artemether-lumefantrine
    Primary Outcome Measure Information:
    Title
    Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).
    Secondary Outcome Measure Information:
    Title
    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)
    Title
    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)
    Title
    Relationship between changes in auditory function and drug exposure.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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/exclusion criteria may apply.)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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