Tuberculosis Clinical Trial
Official title:
Impact of a Package of Intensive Smoking-cessation Interventions Versus Smoking-cessation Advice on Outcomes in Smear-positive Patients With Pulmonary Tuberculosis; a Randomised Controlled Trial (STB_RCT).
Verified date | October 2017 |
Source | All India Institute of Medical Sciences, New Delhi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to determine the impact of a package of smoking-cessation
interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.
Given the lack of objective clinical data/evidence about the impact of smoking-cessation on
TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to
be beneficial particularly in patients with TB, this study proposes to determine the impact
of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation
(counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis
therapy. This is to be compared with the structured counselling for smoking-cessation that is
recommended to be routinely provided by health care workers to all patients who are smokers.
If the results prove that such a smoking-cessation PI indeed improves outcomes in TB
patients, such information would strongly motivate for the institution of more intensive
smoking-cessation interventions in TB clinics than is currently being employed for TB
patients
Status | Completed |
Enrollment | 800 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - any adult (> 18 years) - Recently diagnosed (primary TB/Relapse TB) smear-positive TB patient who self-reports to smoke at least 10 whole cigarettes or bidis (rolled tobacco leaf) per day, every day Exclusion Criteria: - patients will be excluded from recruitment to the study if they fall into any one or more of these exclusion categories: - Inability to give consent or < 18 years - Patients who self-report to smoke less than 10 whole cigarettes/bidis per day - TB patients who have already started anti-tuberculosis therapy for more than 1 week. - Patients with known multidrug-resistant TB (or XDR) (information provided by patient or the information is available in the clinic folder). - Known HIV-positive patients - Contra-indications to NRT (patients with a history of severe cardiovascular disease including arrhythmias, recent myocardial infarction (within the last 6 months), recent cerebrovascular incident (6 months), and/ or history of peripheral vascular disease, phaeochromocytoma, poorly controlled diabetes mellitus, hyperthyroidism, renal/hepatic impairment or gastritis/peptic ulcers). Patients with asthma or depression will also be excluded, as quitting may have an effect on medications used for these conditions. Patients with severe skin disorders (such as psoriasis or eczema) will also be excluded. |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences, Ansari Nagar | New Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi | Sri Venkateswara Institute of Medical Sciences University, University of Cape Town |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1. Change in TB Score at second month and sixth month | Composite score for objective and subjective improvement measured at baseline, second month and sixth month | Measured at baseline, second month and sixth month. | |
Primary | Sputum culture conversion | Sputum culture conversion at second month using solid/liquid culture technique | Measured at baseline and second month | |
Secondary | Sputum smear conversion | Protocol was amended to access sputum conversion weekly up to second month | Measured at baseline, second week, fourth week, second month and sixth months | |
Secondary | Mortality at sixth month | To determine number of mortality at the end of follow-up | Sixth month | |
Secondary | More than 10% weight gain at six months | To determine rate of weight gain after completion of treatment | Sixth month | |
Secondary | Proportion of subjects in each group that have quit smoking at second month | To determine the rate of smoking cessation in the cohort | Sixth month | |
Secondary | Treatment completion | Six months for new cases and eight months for re-treatment cases following regimen 2 | ||
Secondary | Cure, failure and default rate | To determine cure, failure and default rate in the cohort | At sixth month |
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