A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis
| ISRCTN | ISRCTN53339491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53339491 |
| Secondary identifying numbers | 07.35; A70394 |
- Submission date
- 23/01/2008
- Registration date
- 08/04/2008
- Last edited
- 24/10/2016
- 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 Luis Cuevas
Scientific
Scientific
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)151 705 3219 |
|---|---|
| lcuevas@liv.ac.uk |
Study information
| Study design | Interventional randomised controlled two-armed study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis |
| Study acronym | TB-TSDSS (TuBerculosis - Two Same Day Sputum Specimens) |
| Study objectives | 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 |
| Ethics approval(s) | 1. World Health Organization (WHO) Research Ethics Committee, September 2007 2. Nigeria National Ethics Committee, 23/07/2007 3. Brazil National Ethics Committee, 12/10/2007 4. Ethopia National Ethics Committee, 10/01/2008 5. Nepal National Ethics Committee, 22/07/2007 6. Yemen National Ethics Committee, 27/06/2007 6. Liverpool School of Tropical Medicine Research Ethics Committee, 07/06/2007, ref: 07.35 |
| Health condition(s) or problem(s) studied | Tuberculosis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 06/01/2008 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 6852 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/01/2008 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Brazil
- England
- Ethiopia
- Nepal
- Nigeria
- United Kingdom
- Yemen
Study participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
L3 5QA
United Kingdom
Sponsor information
Liverpool School of Tropical Medicine (UK)
University/education
University/education
Pembroke Place
Liverpool
L3 5QA
England
United Kingdom
| Phone | +44 (0)151 705 3281 |
|---|---|
| hemingway@liv.ac.uk | |
| Website | http://www.liv.ac.uk/lstm/ |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Research organisation
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)
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 | 01/07/2011 | Yes | No | |
| Results article | results | 01/07/2011 | Yes | No | |
| Results article | results | 24/03/2016 | Yes | No |
Editorial Notes
24/10/2016: Publication reference added.
