Treatment of Non-Falciparum Malaria

This study is currently recruiting participants.

Verified by Albert Schweitzer Hospital, Netherlands, June 2008

Sponsored by:	Albert Schweitzer Hospital, Netherlands
Information provided by:	Albert Schweitzer Hospital, Netherlands
ClinicalTrials.gov Identifier:	NCT00725777

Purpose

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	Intervention
Acute Non-Falciparum Malaria	Drug: artemether-lumefantrine

MedlinePlus related topics: Malaria

Drug Information available for: Artemether Benflumetol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Albert Schweitzer Hospital, Netherlands:

Primary Outcome Measures:

Parasitological cure rate on day 28 [ Time Frame: D28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency and severity of drug related adverse events [ Time Frame: D28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: artemether-lumefantrine Standard artemether-lumefantrine treatment

Eligibility

Ages Eligible for Study:	6 Months to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725777

Contacts

Contact: Sabine Bélard, MD

0024107552873

sabinebelard@yahoo.de

Locations

Gabon, Moyen Ogooue
Medical Research Unit of the Albert Schweitzer Hospital	Recruiting
Lambaréné, Moyen Ogooue, Gabon, BP 118
Contact: Sabine Bélard, MD 0024107552873 sabinebelard@yahoo.de
Principal Investigator: Sabine Bélard, MD

Sponsors and Collaborators

Albert Schweitzer Hospital, Netherlands

Investigators

Principal Investigator:

Sabine Bélard, MD

Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné

More Information

Responsible Party:	Medical Research Unit of the Albert Schweitzer Hospital ( Sabine Bélard Principle Investigator )
Study ID Numbers:	IDC-08-01
Study First Received:	July 14, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00725777
Health Authority:	Gabon: Ministry of Health

Study placed in the following topic categories:

Benflumetol
Artemether-lumefantrine combination
Protozoan Infections
Clotrimazole
Miconazole

Tioconazole
Parasitic Diseases
Malaria
Artemether

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antiplatyhelmintic Agents
Coccidiosis

Antifungal Agents
Therapeutic Uses
Anthelmintics
Coccidiostats
Schistosomicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009