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Can Treatment of Malaria be Restricted to Parasitologically Confirmed Malaria?

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ClinicalTrials.gov Identifier: NCT00913146
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : June 4, 2009
Sponsor:
Collaborator:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Information provided by:
Institut de Recherche pour le Developpement

Brief Summary:
The investigators performed a prospective study, in order to assess the feasibility and safety of restricting antimalarials to rapid diagnostic test (RDT)-confirmed cases in children aged 5 to 15 years-old

Condition or disease
Malaria

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 484 participants
Time Perspective: Prospective
Official Title: Can Treatment of Malaria be Restricted to Parasitologically Confirmed Malaria? A School-Based Prospective, Exposed/Non Exposed to Fever, Study in Benin.
Study Start Date : February 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Group/Cohort
index
child with fever and a negative malaria RDT
control
apparently healthy child with a negative RDT



Primary Outcome Measures :
  1. malaria incidence in the 2 groups (index and control) [ Time Frame: after 14 days of follow-up ]

Secondary Outcome Measures :
  1. malaria incidence in children with a positive Plasmodium falciparum PCR at baseline [ Time Frame: after 14 days of follow-up ]

Biospecimen Retention:   Samples With DNA
whole blood dried on filter papers


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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
2600 schoolchildren of 5 years-old and above
Criteria

Inclusion Criteria in the index group:

  • School children aged 5 to 15 years.
  • Tympanic temperature at 37.8°C or above, or if a history of fever in the preceding 24 hours was reported.
  • A negative malaria (Paracheck® Plasmodium falciparum) RDT.
  • Informed consent.
  • Asymptomatic children were screened for the Control Group on gender, age, week of inclusion. The first child with a negative RDT and for whom an informed consent was obtained, was included in the CG.

Exclusion Criteria:

  • Adequate malaria treatment within a month prior screening.

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): NCT00913146


Locations
Benin
Centre de Santé de Commune
Allada, Benin
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Investigators
Principal Investigator: Jean-François Faucher, MD, PhD IRD

Publications:
Responsible Party: Jean-François Faucher, MD, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT00913146     History of Changes
Other Study ID Numbers: IMEA5982FAU90
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Keywords provided by Institut de Recherche pour le Developpement:
Management of fever
Malaria
Malaria rapid diagnostic test
Clinical trial

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases