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

NCT00317590 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2007-10-31

No results posted yet for this study

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

Interventions

DEVICE

Rapid Diagnostic Test for Malaria (Paracheck®)

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Centro per le Malattie Tropicali

    lead OTHER

Principal Investigators

  • Zeno Bisoffi, MD, DTM&H · Centro per le Malattie Tropicali, Ospedale S. Cuore, Negrar (Verona), Italy

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Completion
2006-10-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00317590 on ClinicalTrials.gov