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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
  Email 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
  Email 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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