Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pragmatic clinical trial and cost-effectiveness evaluation of techniques for the sensitive and resistant tuberculosis diagnosis in patients assisted at two hospitals in Rio de Janeiro - Brazil
Acronym
RapTB
Study hypothesis
The implantation of a new technology (BD960) for the tuberculosis (TB), multi-drug resistant (MDR)/TB investigation in hospital units, besides reducing the intra-hospital TB transmission and the cost of the hospitalised patients treatment, will also greatly reduce the morbid/lethality of TB patients.
Ethics approval
Approved by the Research Ethics Committee of University Hospital Clementino Fraga Filho at the Federal University of Rio de Janeiro (ref: 020/07)
Study design
Pragmatic multicentre open randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Tuberculosis
Intervention
The diagnostic test used in the routine, the Löwenstein Jensen Proportion Method, will be compared to BACTEC™ MGIT™ 960 System.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Proportion of patients for whom medical procedure is changed
after 60 days (stopping or initiating anti-TB drugs).
Secondary outcome measures
Patients will be followed for 180 days after randomisation. At the end of this period
we will measure:
1. Number of participants lost to follow-up
2. Number of deaths by any cause in the patients included in the study
3. Number of adverse effects to the drugs
4. Proportion of patients with TB diagnosis sensitive or resistant to anti-TB drugs
5. Proportion of patients that undergo anti-TB treatment failure during the therapy
6. Proportion of drug resistant TB development in the patients
7. Time to sensitivity determination to drugs
8. Proportion of bacteriological conversion (bacilloscopy and culture for mycobacterium) due to the anti-TB treatment at the end of the second and sixth month of anti-TB treatment
9. Cost of the pulmonary TB diagnostic test, for each test, and for the anti-TB treatment
10. Cost of the resistant pulmonary TB diagnostic test for each test and for the anti-TB treatment
11. Cost for the patient and family nucleus in relation to the TB diagnosis
12. Cost for the public health system (SUS) in relation to the TB diagnosis
13. Proportion of necessary human resources for the accomplishment of the TB diagnostic
test
14. Proportion of necessary human resources for the resistant TB diagnostic test
Overall trial start date
01/08/2008
Overall trial end date
01/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Individuals aged 18 years or more, either sex
2. Assisted in two university hospitals in the southeast area of Brazil
3. Under tuberculosis suspicion (TB)
4. With or without anti-TB treatment in the past
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
706 individuals
Participant exclusion criteria
Individuals who refuse to participate
Recruitment start date
01/08/2008
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Brazil
Trial participating centre
INCQS - Instituto Nacional de Controle em Qualidade de Saúde
Rio de Janeiro
21.040-900
Brazil
Sponsor information
Organisation
Brazilian Tuberculosis Research Network (Rede Brasileira de Pesquisa em Tuberculose [REDE-TB]) (Brazil)
Sponsor details
Av. Carlos Chagas Filho
791 - Cidade Universitária
Ilha do Fundão
Rio de Janeiro
21941-904
Brazil
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Brazilian Ministry of Health/UNESCO (Brazil) - Pragmatic Diagnostic Trials on TB (ref: 914BRA2000 - DECIT PRODOC, Processo FUJB no. 11.125-2)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 Conference proceedings (abstract in Portugese)
Rapid-TB - A pragmatic clinical trial to evaluate cost-effectiveness of diagnostic tests for tuberculosis: MGIT vs LJ. (Rapid-TB - Um ensaio clínico pragmático para
avaliação de custo-efetividade dos testes diagnósticos em tuberculose: MGIT vs L-J)
Rezende, AS; Castro, CBA; AguirR, FS; Marsico AG; Costa, PA; Vieira, Mams; Vieira,
GBO; Fonseca, LS; Huf G; Kritski AL. 3rd National Meeting on Tuberculosis, Salvador. Jornal Brasileiro de Pneumologia. 2008. v.34. p.21 21.
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23857683
Publication citations
-
Results
Moreira Ada S, Huf G, Vieira MA, Fonseca L, Ricks M, Kritski AL, Performance comparison between the mycobacteria growth indicator tube system and Löwenstein-Jensen medium in the routine detection of Mycobacterium tuberculosis at public health care facilities in Rio de Janeiro, Brazil: preliminary results of a pragmatic clinical trial., J Bras Pneumol, 39, 3, 365-367, doi: 10.1590/S1806-37132013000300014.