- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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New Delhi, Inde, 110029
- All India Institute of Medical Sciences, Ansari Nagar
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: 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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Comparateur actif: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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1. Change in TB Score at second month and sixth month
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sputum smear conversion
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Surendra K Sharma, MD, Ph.D., AIIMS, New Delhi
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections bactériennes à Gram positif
- Infections à Actinomycétales
- Infections à mycobactéries
- Tuberculose
- Tuberculose pulmonaire
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents cholinergiques
- Stimulants ganglionnaires
- Agonistes nicotiniques
- Agonistes cholinergiques
- Nicotine
Autres numéros d'identification d'étude
- SKS/Med/NI1161
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