A multi-centric trial of front-loaded smear microscopy in the diagnosis of tuberculosis

ISRCTN	ISRCTN53339491
DOI	https://doi.org/10.1186/ISRCTN53339491
Protocol serial number	07.35; A70394
Sponsor	Liverpool School of Tropical Medicine (UK)
Funder	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)

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

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom

Phone	+44 (0)151 705 3219
Email	lcuevas@liv.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional randomised controlled two-armed study
Secondary study design	Randomised controlled trial
Study type	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(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
Key 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
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England
Brazil
Ethiopia
Nepal
Nigeria
Yemen

Study participating centre

Liverpool School of Tropical Medicine

Liverpool
L3 5QA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/10/2016: Publication reference added.