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22 May 2013
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| [ Print-friendly version ] |
| A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis |
| ISRCTN | ISRCTN53339491 |
| DOI | 10.1186/ISRCTN53339491 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis |
| Scientific title | |
| Acronym | TB-TSDSS (TuBerculosis - Two Same Day Sputum Specimens) |
| Serial number at source | 07.35; A70394 |
| Study hypothesis |
1. To determine the sensitivity, specificity and predictive values of a "two samples in a single day" strategy for the diagnosis of tuberculosis (TB) and compare it to the standard strategy
2. To determine the proportion of patients who could initiate treatment (or who are referred to initiate treatment) 24, 48 or greater than or equal to 72 hours after consultation by the "two samples in a single day" and the standard strategies 3. To describe the effect of using different thresholds to define a positive smear and a smear positive case on the yield of the "two samples in a single day" and standard strategies |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Ethics approval received from:
1. World Health Organization (WHO) Research Ethics Committee in September 2007 2. Nigeria National Ethics Committee on the 23rd July 2007 3. Brazil National Ethics Committee on the 12th October 2007 4. Ethopia National Ethics Committee on the 10th January 2008 5. Nepal National Ethics Committee on the 22nd July 2007 6. Yemen National Ethics Committee on the 27th June 2007 6. Liverpool School of Tropical Medicine Research Ethics Committee on the 7th June 2007 (ref: 07.35) |
| Study design | Interventional randomised controlled two-armed study |
| Countries of recruitment | Brazil, Ethiopia, Nepal, Nigeria, Yemen |
| Disease/condition/study domain | Tuberculosis |
| Participants - inclusion criteria |
1. Symptoms suggesting pulmonary TB: persistent cough (generally greater than two weeks)
2. Provision of informed consent to participation 3. Age greater than 18 years old, either sex |
| Participants - exclusion criteria |
1. Inability to provide informed consent (e.g., unfamiliarity with language of patient information/consent forms, prisoners, mentally impaired)
2. Anti-tuberculous treatment in the last month |
| Anticipated start date | 06/01/2008 |
| Anticipated end date | 01/01/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 6852 |
| Interventions |
Scheme one: experimental arm -
Each patient attending during this week will be requested to provide: 1. One on-the-spot sputum sample at the time of the patient's first visit 2. A second on-the-spot sample taken one hour after the first one 3. An early morning sputum sample taken by the patient at home on the day following the initial visit Scheme two: current standard - Each patient attending during this week will be requested to provide: 1. One on-the-spot sputum sample at the time of the patient's first visit 2. An early morning sputum sample taken by the patient at home on the day following the initial visit 3. A second on-the-spot sample taken at the time the patient brings his early morning sample There is no long term follow up of patients. Patients are managed by the National TB control programmes. It is intended that enrolment of patients will take a minimum of 10 months and may continue until the sample size is complete. |
| Primary outcome measure(s) |
These outcomes will be established for each diagnostic strategy and will use culture as gold standard:
1. Sensitivity, specificity, positive and negative predictive value of smear microscopy when using: 1.1. The WHO case definitions for smear-positive tuberculosis 1.2. The first two specimens collected by each strategy (spot and extra-spot versus spot and morning) 2. The number of patients referred to a TB treatment centre 24, 48 and 72 hours after their initial consultation 3. The number of patients who drop out of the diagnostic process |
| Secondary outcome measure(s) |
1. Sensitivity, specificity, positive and negative predictive value of:
1.1. A single positive smear 1.2. A single positive smear considering smears with scanty acid-fast bacilli (AFB) as positive 1.3. The smears collected as spot, extra-spot and morning or spot-morning-spot 2. Proportion of patients with positive culture identified by two smears prepared from a single specimens 3. The incremental yield of the second and third samples |
| Sources of funding | United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR) |
| Trial website | |
| Publications |
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21765808
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21765809 |
| Contact name | Dr Luis Cuevas |
| Address |
Liverpool School of Tropical Medicine
Pembroke Place |
| City/town | Liverpool |
| Zip/Postcode | L3 5QA |
| Country | United Kingdom |
| Tel | +44 (0)151 705 3219 |
| Fax | +44 (0)151 705 3329 |
| lcuevas@liv.ac.uk | |
| Sponsor | Liverpool School of Tropical Medicine (UK) |
| Address | Pembroke Place |
| City/town | Liverpool |
| Zip/Postcode | L3 5QA |
| Country | United Kingdom |
| Tel | +44 (0)151 705 3281 |
| Fax | +44 (0)151 705 3371 |
| hemingway@liv.ac.uk | |
| Sponsor website: | http://www.liv.ac.uk/lstm/ |
| Date applied | 23/01/2008 |
| Last edited | 10/11/2011 |
| Date ISRCTN assigned | 08/04/2008 |
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