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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
RBR-88b5jr |
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Date of registration:
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11/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diagnostic study of Dengue in Emergency Care
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Scientific title:
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Pragmatic Diagnostic Trial of Cinical-Laboratory Algorithm for Dengue in Emergency Care Units in Rio de Janeiro |
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Date of first enrolment:
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05/04/2013 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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http://ensaiosclinicos.gov.br/rg/RBR-88b5jr |
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Study type:
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Intervention |
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Study design:
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Two arms, double-blind, paralle, randomized, diagnostic clinical trial
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Sibelle Nogueira
Buonora |
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Address:
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Rua Bruno Lobo 50 Ilha do Fundão
21000-000
Rio de Janeiro
Brazil |
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Telephone:
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+55(21)998727696 |
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Email:
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sibellebuonora@gmail.com |
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Affiliation:
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Universidade Federal do Rio de Janeiro |
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Name:
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Sonia Regina Lambert
Passos |
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Address:
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Av Brasil 4036 sala 201 A Manguinhos
21040-361
Manguinhos
Brazil |
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Telephone:
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+55(21)38829208 |
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Email:
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sonia.lambert@ipec.fiocruz.br |
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Affiliation:
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Instituto de Pesquisa Clínica Evandro Chagas |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients of both genders over 18 years assisted in Emergency Care Units in Rio de Janeiro, with fever for up to 3 days without other infectious etiology.
Exclusion criteria: pediatric patients and those with other infectious etiology.
Age minimum:
18Y
Age maximum:
100Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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C02.081.270
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Dengue
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Intervention(s)
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Procedure/surgery
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Different algorithms clinical diagnosis of dengue will be compared in a outpatient unit. Control Group ( clinical algorithm proposed by WHO 2009): 150 subjects will undergo the standard protocol for the diagnosis of dengue consisting of at least two of seven signs and symptoms (fever, myalgia, asthenia, headache, retrorbitrária pain, arthralgia, rash) and Intervention Group: 150 individuals will be subjected to the experimental protocol for the diagnosis of dengue, which consists of (lymphadenopathy, leukocyte count below 6000/mm3, rash, thrombocytopenia, ocular congestion. Both groups will be subjected to rapid immunochromatographic dengue dengue NS1 (Bio-Easy)
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E01.370
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Primary Outcome(s)
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Accurate, more sensitive and specific case definition to guide the rapid test request and appropriate referral of the case. To compare Likelihood Ratios and Diagnostic Odds Ratios of each model.
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Reliability of each clinical prediction rule measured by kappa values ??interpreted according to Landis and Koch, 1977.
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Secondary Outcome(s)
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Need to review clinical case defined as at least a return to emergency unit
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Source(s) of Monetary Support
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Fundação Oswaldo Cruz
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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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