Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis
23 mei 2017 bijgewerkt door: Weill Medical College of Cornell University
Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization towards a distinct phenotype associated with impaired host defense function against Mtb and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.
Studie Overzicht
Toestand
Ingetrokken
Gedetailleerde beschrijving
Samples from Non-Smokers with TB, Smokers with TB and Smokers with COPD and TB will be collected in Qatar under JIRB 14-00055.
All subjects will be undergoing a clinical bronchoscopy as part of their disease evaluation and will be asked to give additional samples for research.
All "in vivo" processing of specimens from subjects with TB will be performed in Qatar.
Mycobacterium tuberculosis infection (Mtb) continues to have a detrimental impact of public health worldwide.
Based on the epidemiological evidence linking smoking, COPD and Mtb, and our preliminary data we hypothesize that smoking reprograms Alveolar Macrophages (AM) polarization towards a distinct phenotype associated with impaired host defense function against Myobacterium tuberculosis (Mtb) and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophages (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.
Studietype
Observationeel
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Doha, Katar
- Hamad Medical Corporation
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Recruitment will be from the referral base of the responsible investigator and other physicians, and review of admissions and hospital database.
Patients, who may qualify for this study, will be identified by chart review, physician referral, and recruited by study investigators.
The source of potential subjects will be the population of potential subjects with TB (smokers or non smokers), and with both TB and COPD, as defined before.
Accrual will be random with no bias as to gender or racial/ethnic group.
Beschrijving
Smokers and Non-smokers with TB
Inclusion Criteria:
- Must provide informed consent
- Current smokers and non-smokers
- Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
- Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
- Symptoms consistent with TB
- Chest xray and or chest CT with TB
- Positive PPD test
- Positive sputum test
Exclusion Criteria:
- Females who are pregnant or nursing
- History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic
Smokers with TB and COPD
Inclusion Criteria:
- Must provide informed consent
- Current smokers with COPD
- Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
- Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed bu at least one of the following:
- Symptoms consistent with TB
- Chest xray and or chest CT consistent with TB
- Positive PPD test
- Positive sputum test
Exclusion Criteria:
- Non-smokers
- Females who are pregnant or nursing
- History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Individuals with TB
Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
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Smokers
Active smoker as evidenced by self report and urine nicotine >30 ng/mL and urine cotinine >50 ng/mL Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
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Non-smokers
Never smokers is defined as someone who has smoked < 100 cigarettes per lifetime and whose urine nicotine <2 ng/mL and urine cotinine <5 ng/mL, at entry into the study Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
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Individuals with COPD
All study subjects should meet the "Lung Disease" protocol criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Alveolar Macrophage
Tijdsspanne: 1 week
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Changes in alveolar macrophage
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1 week
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Ronald Crystal, MD, Weill Medical College of Cornell University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2014
Primaire voltooiing (Verwacht)
1 oktober 2016
Studie voltooiing (Verwacht)
1 oktober 2016
Studieregistratiedata
Eerst ingediend
22 november 2013
Eerst ingediend dat voldeed aan de QC-criteria
19 december 2013
Eerst geplaatst (Schatting)
27 december 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 mei 2017
Laatste update ingediend die voldeed aan QC-criteria
23 mei 2017
Laatst geverifieerd
1 mei 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 14-00055 [JIRB]
- NPRP 5-400-3-107 (Andere identificatie: Qatar National Research Fund)
- 11262/11 (Andere identificatie: HMC IRB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
All results of the proposed studies will be published in international peer-reviewed scientific journals, presented at meetings in Qatar, the regional and international conferences, and disseminated through the local Qatari media, seminars and lectures for high school and college students.
The original data will be available to interested investigators using the conventional standards of biomedical science.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .