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Treatment of Non-falciparum Malaria

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.
 
ClinicalTrials.gov Identifier: NCT00725777
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
Michael Ramharter, Albert Schweitzer Hospital

Tracking Information
First Submitted Date  ICMJE July 14, 2008
First Posted Date  ICMJE July 30, 2008
Last Update Posted Date February 17, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
Parasitological cure rate on day 28 [ Time Frame: D28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
Frequency and severity of drug related adverse events [ Time Frame: D28 ]
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 Treatment of Non-falciparum Malaria
Official Title  ICMJE Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon
Brief Summary Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Non-falciparum Malaria
Intervention  ICMJE Drug: artemether-lumefantrine
Standard artemether-lumefantrine treatment
Study Arms  ICMJE Experimental: A
Intervention: Drug: artemether-lumefantrine
Publications * Mombo-Ngoma G, Kleine C, Basra A, Würbel H, Diop DA, Capan M, Adegnika AA, Kurth F, Mordmüller B, Joanny F, Kremsner PG, Ramharter M, Bélard S. Prospective evaluation of artemether-lumefantrine for the treatment of non-falciparum and mixed-species malaria in Gabon. Malar J. 2012 Jul 10;11:120. doi: 10.1186/1475-2875-11-120.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
  • Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density > 50-200000/μl of blood
  • Written informed consent

Exclusion Criteria:

  • Patients with presence of other clinical conditions requiring hospitalization
  • Presence of other febrile conditions
  • Presence of significant anemia, defined by hemoglobin < 7g/dl
  • Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
  • Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
  • Pregnant and breast feeding females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gabon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00725777
Other Study ID Numbers  ICMJE IDC-08-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Ramharter, Albert Schweitzer Hospital
Study Sponsor  ICMJE Albert Schweitzer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sabine Bélard, MD Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné
PRS Account Albert Schweitzer Hospital
Verification Date February 2012

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