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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):

Study Description
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.

Condition or disease Intervention/treatment
Acute Non-falciparum Malaria Drug: artemether-lumefantrine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Primary Completion Date : December 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: artemether-lumefantrine
Standard artemether-lumefantrine treatment


Outcome Measures

Primary Outcome Measures :
  1. Parasitological cure rate on day 28 [ Time Frame: D28 ]

Secondary Outcome Measures :
  1. Frequency and severity of drug related adverse events [ Time Frame: D28 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00725777


Locations
Gabon
Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen Ogooue, Gabon, BP 118
Sponsors and Collaborators
Albert Schweitzer Hospital
Investigators
Principal Investigator: Sabine Bélard, MD Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Ramharter, Ass. Prof. PD, Albert Schweitzer Hospital
ClinicalTrials.gov Identifier: NCT00725777     History of Changes
Other Study ID Numbers: IDC-08-01
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics