WGS of NTM From Sputum of NTM Lung Disease Patients and From Their Environments

Nontuberculous Mycobacterium Infection Clinical Trial

— NTM_HOME  

Official title:

Whole Genome Sequencing of Nontuberculous Mycobacterium (NTM) Derived From Sputum Specimen of NTM Lung Disease Patients Living Together and From Their Environmental Samples

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03532438
• Other study ID #: NTM_HOME
• Status: Recruiting
• Start date: May 2018
• Est. completion date: May 2019

Study information

• Verified date: May 2018
• Source: Seoul National University Hospital
• Contact: Jae-June Yim, MD
• Phone: +82-2-2072-2059
• Email: yimjj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the study is to identify the genetic closeness of NTM derived from patients living together and from their surrounding environment and to trace the temporal relationship between them.

Description:

After NTM isolation is done by using culture, from patients' sputum/bronchoscopic samples and their environmental samples, whole genome sequencing (WGS) will be conducted for all NTM isolates. Phylogenetic analysis will be performed based on single nucleotide polymorphism (SNP) on each NTM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The adult over 18 years of age

• The patient who have respiratory symptoms consistent with NTM, such as a chronic cough, sputum, and hemoptysis, who have NTM-positive findings on CT, and who have NTM identification in two or more sputum cultures or in one or more bronchoscopic/tissue culture. (2007 ATS/IDSA guideline)

• Pairs of patients living in the same household since diagnosis on NTM lung disease

• Consent to a collection of environmental samples from the patient's residence.

Exclusion Criteria:

• If the patient does not agree or withdraw.

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Infections
• Mycobacterium Infections, Nontuberculous
• Nontuberculous Mycobacterium Infection
• Whole Genome Sequencing

Locations

Country	Name	City	State
Korea, Republic of	Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Bryant JM, Grogono DM, Greaves D, Foweraker J, Roddick I, Inns T, Reacher M, Haworth CS, Curran MD, Harris SR, Peacock SJ, Parkhill J, Floto RA. Whole-genome sequencing to identify transmission of Mycobacterium abscessus between patients with cystic fibrosis: a retrospective cohort study. Lancet. 2013 May 4;381(9877):1551-60. doi: 10.1016/S0140-6736(13)60632-7. Epub 2013 Mar 29. — View Citation

Bryant JM, Grogono DM, Rodriguez-Rincon D, Everall I, Brown KP, Moreno P, Verma D, Hill E, Drijkoningen J, Gilligan P, Esther CR, Noone PG, Giddings O, Bell SC, Thomson R, Wainwright CE, Coulter C, Pandey S, Wood ME, Stockwell RE, Ramsay KA, Sherrard LJ, Kidd TJ, Jabbour N, Johnson GR, Knibbs LD, Morawska L, Sly PD, Jones A, Bilton D, Laurenson I, Ruddy M, Bourke S, Bowler IC, Chapman SJ, Clayton A, Cullen M, Daniels T, Dempsey O, Denton M, Desai M, Drew RJ, Edenborough F, Evans J, Folb J, Humphrey H, Isalska B, Jensen-Fangel S, Jönsson B, Jones AM, Katzenstein TL, Lillebaek T, MacGregor G, Mayell S, Millar M, Modha D, Nash EF, O'Brien C, O'Brien D, Ohri C, Pao CS, Peckham D, Perrin F, Perry A, Pressler T, Prtak L, Qvist T, Robb A, Rodgers H, Schaffer K, Shafi N, van Ingen J, Walshaw M, Watson D, West N, Whitehouse J, Haworth CS, Harris SR, Ordway D, Parkhill J, Floto RA. Emergence and spread of a human-transmissible multidrug-resistant nontuberculous mycobacterium. Science. 2016 Nov 11;354(6313):751-757. doi: 10.1126/science.aaf8156. — View Citation

Fournier PE, Dubourg G, Raoult D. Clinical detection and characterization of bacterial pathogens in the genomics era. Genome Med. 2014 Nov 29;6(11):114. doi: 10.1186/s13073-014-0114-2. eCollection 2014. — View Citation

Roach DJ, Burton JN, Lee C, Stackhouse B, Butler-Wu SM, Cookson BT, Shendure J, Salipante SJ. A Year of Infection in the Intensive Care Unit: Prospective Whole Genome Sequencing of Bacterial Clinical Isolates Reveals Cryptic Transmissions and Novel Microbiota. PLoS Genet. 2015 Jul 31;11(7):e1005413. doi: 10.1371/journal.pgen.1005413. eCollection 2015 Jul. Erratum in: PLoS Genet. 2017 Apr 14;13(4):e1006724. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic similarity of NTM(Non-Tuberculous Mycobacterium)	Concordance of Single Nucleotide Polymorphisms (SNP) from NTMs derived from patients and their environments	Baseline