Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis
23. maj 2017 opdateret af: 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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Doha, Qatar
- Hamad Medical Corporation
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Alveolar Macrophage
Tidsramme: 1 week
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Changes in alveolar macrophage
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1 week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ronald Crystal, MD, Weill Medical College of Cornell University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2014
Primær færdiggørelse (Forventet)
1. oktober 2016
Studieafslutning (Forventet)
1. oktober 2016
Datoer for studieregistrering
Først indsendt
22. november 2013
Først indsendt, der opfyldte QC-kriterier
19. december 2013
Først opslået (Skøn)
27. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14-00055 [JIRB]
- NPRP 5-400-3-107 (Anden identifikator: Qatar National Research Fund)
- 11262/11 (Anden identifikator: HMC IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .