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

This study has been completed.
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by:
Centro per le Malattie Tropicali
ClinicalTrials.gov Identifier:
NCT00317590
First received: April 23, 2006
Last updated: October 30, 2007
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00317590     History of Changes
Other Study ID Numbers: AnKaHeresoRDT
Study First Received: April 23, 2006
Last Updated: October 30, 2007
Health Authority: Burkina Faso: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014