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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on November 20, 2014