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Effectiveness and Cost-Effectiveness of a Rapid Diagnostic Test for Malaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317590
First Posted: April 25, 2006
Last Update Posted: October 31, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by:
Centro per le Malattie Tropicali
  Purpose

There is increasing evidence from African countries, including Burkina Faso, that at least in some settings/seasons the proportion of fevers attributable to malaria is low or very low: this means that the current strategy of treating all fever cases as malaria is only to the advantage of very few. Rapid, antigenic tests might be of help, particularly in peripheral health centres such as the "Centres de Santé et Promotion Sociale" (CSPS) that lack any laboratory facilities. Nevertheless two major problems could arise:

  • False negatives: as only the negative result would change the decision to treat, versus the current "presumptive" strategy, false negatives would not be treated for malaria.
  • False positives: they would be exposed to the risk to be left without treatment for the true cause of their fever instead.

The main purpose of this study is to assess if the short term outcome of febrile patients treated after testing with the Rapid Diagnostic Test Paracheck® is at least equivalent (not inferior) to that of controls (presumptively treated without any test) in terms of clearance of fever and other major symptoms and signs.

To do so, febrile patients will be randomly assigned to be submitted to the test before clinical decision, or to be managed the usual way with no test. A follow up will be carried out at Day 4th in order to determine the proportion of patients in both groups with persistence of fever and other main clinical symptoms.


Condition Intervention Phase
Malaria Device: Rapid Diagnostic Test for Malaria (Paracheck®) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation de l'utilité et du coût-efficacité du Test Rapide Paracheck® Pour la Prise en Charge Des Cas de Paludisme Dans Les régions Des Hauts Bassins et Des Cascades, au Burkina Faso

Resource links provided by NLM:


Further study details as provided by Centro per le Malattie Tropicali:

Primary Outcome Measures:
  • Clearance of fever

Secondary Outcome Measures:
  • Clearance of major clinical symptoms/signs
  • Attributable fraction (AF) of fever episodes to malaria
  • Performances of Paracheck® (sensitivity, specificity and predictive values) on malaria disease
  • Cost-effectiveness of Paracheck® vs. presumptive (clinical) management of fever

Estimated Enrollment: 4000
Study Start Date: April 2006
Study Completion Date: October 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients > 6 months presenting to clinical consultation and consenting to participate/with parental consent to participate.

Exclusion Criteria:

  • Refusal to participate.
  • Severe clinical conditions with emergency treatment needed as judged by the clinical officer.

Pregnancy NOT an exclusion criterion

  Contacts and Locations
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): NCT00317590


Locations
Burkina Faso
Districts Médicaux de Banfora et de Bobo 15
Bobo Dioulasso, Hauts Bassins, Burkina Faso
Sponsors and Collaborators
Centro per le Malattie Tropicali
Institute of Tropical Medicine, Belgium
Investigators
Principal Investigator: Zeno Bisoffi, MD, DTM&H Centro per le Malattie Tropicali, Ospedale S. Cuore, Negrar (Verona), Italy
  More Information

ClinicalTrials.gov Identifier: NCT00317590     History of Changes
Other Study ID Numbers: AnKaHeresoRDT
First Submitted: April 23, 2006
First Posted: April 25, 2006
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by Centro per le Malattie Tropicali:
Diagnosis
Rapid Diagnostic Test
Management
Attributable Fraction
Threshold

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases