Condition category
Infections and Infestations
Date applied
23/01/2008
Date assigned
08/04/2008
Last edited
10/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.liv.ac.uk/lstm/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes