Contact information
Type
Scientific
Primary contact
Dr Luis Cuevas
ORCID ID
Contact details
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3219
lcuevas@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07.35; A70394
Study information
Scientific title
Acronym
TB-TSDSS (TuBerculosis - Two Same Day Sputum Specimens)
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
06/01/2008
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
6852
Participant 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
Recruitment start date
06/01/2008
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Brazil, Ethiopia, Nepal, Nigeria, Yemen
Trial participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
Sponsor information
Organisation
Liverpool School of Tropical Medicine (UK)
Sponsor details
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3281
hemingway@liv.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21765808
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21765809
Publication citations
-
Results
Cuevas LE, Yassin MA, Al-Sonboli N, Lawson L, Arbide I, Al-Aghbari N, Sherchand JB, Al-Absi A, Emenyonu EN, Merid Y, Okobi MI, Onuoha JO, Aschalew M, Aseffa A, Harper G, de Cuevas RM, Kremer K, van Soolingen D, Nathanson CM, Joly J, Faragher B, Squire SB, Ramsay A, A multi-country non-inferiority cluster randomized trial of frontloaded smear microscopy for the diagnosis of pulmonary tuberculosis., PLoS Med., 2011, 8, 7, e1000443, doi: 10.1371/journal.pmed.1000443.
-
Results
Cuevas LE, Al-Sonboli N, Lawson L, Yassin MA, Arbide I, Al-Aghbari N, Sherchand JB, Al-Absi A, Emenyonu EN, Merid Y, Okobi MI, Onuoha JO, Aschalew M, Aseffa A, Harper G, de Cuevas RM, Theobald SJ, Nathanson CM, Joly J, Faragher B, Squire SB, Ramsay A, LED fluorescence microscopy for the diagnosis of pulmonary tuberculosis: a multi-country cross-sectional evaluation., PLoS Med., 2011, 8, 7, e1001057, doi: 10.1371/journal.pmed.1001057.