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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN34123170 |
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Date of registration:
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03/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Increasing tuberculosis case detection and reducing gender disparities through sputum submission instructions: a randomised controlled trial in Pakistan
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Scientific title:
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Date of first enrolment:
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01/07/2005 |
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Target sample size:
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2600 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN34123170 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Diagnostic)
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Phase:
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Peter
Godfrey-Faussett |
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Address:
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Keppel Street
WC1E 7HT
London
United Kingdom |
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Telephone:
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Email:
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pgf@lshtm.ac.uk |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: New male and female tuberculosis (TB) suspects, who were referred by TB centre physicians for initial diagnostic sputum testing, were eligible to participate in the trial. According to the National Tuberculosis Control programme guidelines, the criteria for enrolment were:
1. History of a cough for >3 weeks and/or fever for 1 month
2. Blood in sputum
3. Night sweats
4. Weight loss
5. Loss of appetite
Exclusion criteria: 1. Age over 75 or below 14 years
2. History of TB diagnosis or treatment
3. Intake of oral steroids in the 3 months leading up to presentation
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
Infections and Infestations
Tuberculosis
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Intervention(s)
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Patients in the intervention arm were referred to a designated room at the TB centre where they received guidance from a female health worker who was trained by the researcher and a senior TB control officer to provide sputum submission instructions. The female health worker was not involved in recruitment or randomisation. The following points were explained in detail to patients:
1. The importance of submitting sputum rather than saliva, and a description of visual difference between the two
2. The technique that should be used to produce a good sputum specimen (?take three deep breaths, followed by a deep cough to bring up sputum from your lungs?)
3. The necessity of filling at least one-quarter of the container (5 ml), shown by pointing out the required level on a demonstration container
4. The importance of providing one ?spot? specimen and returning the next day with another specimen which has been expectorated on awakening that morning
Following instructions, which lasted between 2-3 min, patients in the intervention group were directed to the laboratory to obtain sputum submission containers.
Control group: usual procedure
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Primary Outcome(s)
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The primary outcome measure was specimen smear-positivity.
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Secondary Outcome(s)
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The secondary outcome, specimen quality, was determined by visual assessment of specimens and microscopic assessment of Ziehl-Neelsen (ZN) stained smears, using a modification of the rating system of Bartlett.
Specimens with a purulent/mucoid/blood-stained visual appearance and/or containing polymorphoneutrophils (PMNs) on microscopic inspection were designated ?sputum?.
Specimens with a clear/watery appearance containing squamous epithelial cells, but no PMNs were designated ?saliva?.
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Source(s) of Monetary Support
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Department for International Development (DFID) (UK) - Knowledge Programme on Tuberculosis
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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