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11 February 2012
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| [ Print-friendly version ] |
| RapTB - evaluation of techniques for tuberculosis diagnosis |
| ISRCTN | ISRCTN79888843 |
| ClinicalTrials.gov identifier | |
| Public title | RapTB - evaluation of techniques for tuberculosis diagnosis |
| 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 |
| Serial number at source | N/A |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Brazil |
| Disease/condition/study domain | Tuberculosis |
| Participants - 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 |
| Participants - exclusion criteria | Individuals who refuse to participate |
| Anticipated start date | 01/08/2008 |
| Anticipated end date | 01/09/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 706 individuals |
| Interventions | The diagnostic test used in the routine, the Löwenstein Jensen Proportion Method, will be compared to BACTEC™ MGIT™ 960 System. |
| Primary outcome measure(s) |
Proportion of patients for whom medical procedure is changed
after 60 days (stopping or initiating anti-TB drugs). |
| 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 |
| Sources of funding | Brazilian Ministry of Health/UNESCO (Brazil) - Pragmatic Diagnostic Trials on TB (ref: 914BRA2000 - DECIT PRODOC, Processo FUJB no. 11.125-2) |
| Trial website | |
| Publications |
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. |
| Contact name | Dr Gisele Huf |
| Address |
INCQS - Instituto Nacional de Controle em Qualidade de Saúde
Av. Brasil, 4365 - Manguinhos |
| City/town | Rio de Janeiro |
| Zip/Postcode | 21.040-900 |
| Country | Brazil |
| Sponsor | Brazilian Tuberculosis Research Network (Rede Brasileira de Pesquisa em Tuberculose [REDE-TB]) (Brazil) |
| Address |
Av. Carlos Chagas Filho,
791 - Cidade Universitária, Ilha do Fundão |
| City/town | Rio de Janeiro |
| Zip/Postcode | 21941-904 |
| Country | Brazil |
| Sponsor website: | http://www.redetb.org |
| Date applied | 05/05/2009 |
| Last edited | 07/01/2010 |
| Date ISRCTN assigned | 07/01/2010 |
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