RapTB - evaluation of techniques for tuberculosis diagnosis

ISRCTN	ISRCTN79888843
DOI	https://doi.org/10.1186/ISRCTN79888843
Protocol serial number	N/A
Sponsor	Brazilian Tuberculosis Research Network (Rede Brasileira de Pesquisa em Tuberculose [REDE-TB]) (Brazil)
Funder	Brazilian Ministry of Health/UNESCO (Brazil) - Pragmatic Diagnostic Trials on TB (ref: 914BRA2000 - DECIT PRODOC, Processo FUJB no. 11.125-2)

Submission date: 05/05/2009
Registration date: 07/01/2010
Last edited: 17/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gisele Huf
Scientific

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

Study information

Primary study design	Interventional
Study design	Pragmatic multicentre open randomised clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	RapTB
Study objectives	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(s)	Approved by the Research Ethics Committee of University Hospital Clementino Fraga Filho at the Federal University of Rio de Janeiro (ref: 020/07)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Proportion of patients for whom medical procedure is changed after 60 days (stopping or initiating anti-TB drugs).
Key secondary outcome measure(s)	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
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	706
Key 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
Key exclusion criteria	Individuals who refuse to participate
Date of first enrolment	01/08/2008
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

Brazil

Study participating centre

INCQS - Instituto Nacional de Controle em Qualidade de Saúde

Rio de Janeiro
21.040-900
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes