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

NCT00317590 | Completed Phase 4

• 1 other identifier: AnKaHeresoRDT
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

Diagnosis; Rapid Diagnostic Test; Management; Attributable Fraction; Threshold

Outcome Measures

Primary Outcomes (1)

• Clearance of fever

Secondary Outcomes (4)

• 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

Interventions

Rapid Diagnostic Test for Malaria (Paracheck®) DEVICE

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro per le Malattie Tropicali: lead
• Institute of Tropical Medicine, Belgium: collaborator

Study Sites (1)

Districts Médicaux de Banfora et de Bobo 15

Bobo-Dioulasso, Hauts-Bassins Region, Burkina Faso

Location

MeSH Terms

Conditions

Malaria; Disease

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Zeno Bisoffi, MD, DTM&H

  Centro per le Malattie Tropicali, Ospedale S. Cuore, Negrar (Verona), Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2006
• First Posted: April 25, 2006
• Study Start: April 1, 2006
• Study Completion: October 1, 2006
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

BU (1)