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Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children (QALE)

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ClinicalTrials.gov Identifier: NCT00540202
Recruitment Status : Unknown
Verified October 2007 by Makerere University.
Recruitment status was:  Recruiting
First Posted : October 5, 2007
Last Update Posted : October 5, 2007
Sponsor:
Collaborators:
Ministry of Health, Uganda
Uganda Malaria Surveillance Project
Information provided by:
Makerere University

Tracking Information
First Submitted Date  ICMJE October 4, 2007
First Posted Date  ICMJE October 5, 2007
Last Update Posted Date October 5, 2007
Study Start Date  ICMJE September 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2007)
1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2007)
1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group. [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Official Title  ICMJE Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Brief Summary We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.
Detailed Description This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uncomplicated Malaria
Intervention  ICMJE
  • Drug: artemether-lumefantrine
    Tablets taken twice daily for 3 days according to weight based guidelines.
    Other Name: Coartem
  • Drug: Oral quinine
    Quinine tablets given at 10mg/kg 8 hourly for 7 days
Study Arms  ICMJE
  • Experimental: 1.Oral quinine
    Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days
    Intervention: Drug: Oral quinine
  • Active Comparator: 2. Coartem
    Tablets
    Intervention: Drug: artemether-lumefantrine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 4, 2007)
302
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged between 6 and 59 months of age seen at the assessment centre during the study period
  2. With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
  3. With a microscopically confirmed monoinfection of Plasmodium falciparum
  4. Able to tolerate oral therapy,
  5. Whose parents/guardians have provided written informed consent.

Exclusion Criteria:

  1. Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
  2. Evidence of severe malaria.
  3. Residence at more than 20km from the health clinic.
  4. Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00540202
Other Study ID Numbers  ICMJE QALE07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Makerere University
Collaborators  ICMJE
  • Ministry of Health, Uganda
  • Uganda Malaria Surveillance Project
Investigators  ICMJE
Principal Investigator: Ambrose O Talisuna, PhD Ministry of Health, Uganda
PRS Account Makerere University
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP