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Can Treatment of Malaria be Restricted to Parasitologically Confirmed Malaria?

This study has been completed.
Sponsor:
Collaborator:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Information provided by:
Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT00913146
First received: June 3, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Malaria

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: Fever Malaria
U.S. FDA Resources

Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • malaria incidence in the 2 groups (index and control) [ Time Frame: after 14 days of follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • malaria incidence in children with a positive Plasmodium falciparum PCR at baseline [ Time Frame: after 14 days of follow-up ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood dried on filter papers


Enrollment: 484
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
index
child with fever and a negative malaria RDT
control
apparently healthy child with a negative RDT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: June 3, 2009
Last Updated: June 3, 2009
Health Authority: France: IRD

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

ClinicalTrials.gov processed this record on May 19, 2013