- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01517022
Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis
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).
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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New Delhi, India, 110029
- All India Institute of Medical Sciences, Ansari Nagar
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Control arm
Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment
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Comparatore attivo: Intervention arm
Cessation arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along and nicotine replacement therapy(NRT) and routine DOTS treatment
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nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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1. Change in TB Score at second month and sixth month
Lasso di tempo: Measured at baseline, second month and sixth month.
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Composite score for objective and subjective improvement measured at baseline, second month and sixth month
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Measured at baseline, second month and sixth month.
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Sputum culture conversion
Lasso di tempo: Measured at baseline and second month
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Sputum culture conversion at second month using solid/liquid culture technique
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Measured at baseline and second month
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sputum smear conversion
Lasso di tempo: Measured at baseline, second week, fourth week, second month and sixth months
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Protocol was amended to access sputum conversion weekly up to second month
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Measured at baseline, second week, fourth week, second month and sixth months
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Mortality at sixth month
Lasso di tempo: Sixth month
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To determine number of mortality at the end of follow-up
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Sixth month
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More than 10% weight gain at six months
Lasso di tempo: Sixth month
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To determine rate of weight gain after completion of treatment
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Sixth month
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Proportion of subjects in each group that have quit smoking at second month
Lasso di tempo: Sixth month
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To determine the rate of smoking cessation in the cohort
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Sixth month
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Treatment completion
Lasso di tempo: Six months for new cases and eight months for re-treatment cases following regimen 2
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Six months for new cases and eight months for re-treatment cases following regimen 2
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Cure, failure and default rate
Lasso di tempo: At sixth month
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To determine cure, failure and default rate in the cohort
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At sixth month
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Surendra K Sharma, MD, Ph.D., AIIMS, New Delhi
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Malattie polmonari
- Infezioni batteriche
- Infezioni batteriche e micosi
- Infezioni batteriche Gram-positive
- Infezioni da actinomiceti
- Infezioni da micobatteri
- Tubercolosi
- Tubercolosi, Polmonare
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti colinergici
- Stimolanti gangliari
- Agonisti nicotinici
- Agonisti colinergici
- Nicotina
Altri numeri di identificazione dello studio
- SKS/Med/NI1161
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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