Condition category
Infections and Infestations
Date applied
05/05/2009
Date assigned
07/01/2010
Last edited
17/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gisele Huf

ORCID ID

Contact details

INCQS - Instituto Nacional de Controle em Qualidade de Saúde
Av. Brasil
4365 - Manguinhos
Rio de Janeiro
21.040-900
Brazil

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 measures

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

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

http://www.redetb.org

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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes