RapTB - evaluation of techniques for tuberculosis diagnosis
| ISRCTN | ISRCTN79888843 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79888843 |
| Secondary identifying numbers | N/A |
- 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
Scientific
INCQS - Instituto Nacional de Controle em Qualidade de Saúde
Av. Brasil, 4365 - Manguinhos
Rio de Janeiro
21.040-900
Brazil
Study information
| Study design | Pragmatic multicentre open randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/08/2008 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 706 individuals |
| 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
21.040-900
Brazil
Sponsor information
Brazilian Tuberculosis Research Network (Rede Brasileira de Pesquisa em Tuberculose [REDE-TB]) (Brazil)
Research organisation
Research organisation
Av. Carlos Chagas Filho
791 - Cidade Universitária
Ilha do Fundão
Rio de Janeiro
21941-904
Brazil
| Website | http://www.redetb.org |
|---|
Funders
Funder type
Government
Brazilian Ministry of Health/UNESCO (Brazil) - Pragmatic Diagnostic Trials on TB (ref: 914BRA2000 - DECIT PRODOC, Processo FUJB no. 11.125-2)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
