Treatment of Non-falciparum Malaria
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFebruary 17, 2012
February 1, 2012
3.4 years
July 14, 2008
February 16, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Parasitological cure rate on day 28
D28
Secondary Outcomes (1)
Frequency and severity of drug related adverse events
D28
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, BP 118, Gabon
Related Publications (1)
Mombo-Ngoma G, Kleine C, Basra A, Wurbel H, Diop DA, Capan M, Adegnika AA, Kurth F, Mordmuller B, Joanny F, Kremsner PG, Ramharter M, Belard 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.
PMID: 22515681DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Bélard, MD
Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof. PD
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 30, 2008
Study Start
July 1, 2008
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
February 17, 2012
Record last verified: 2012-02