NCT03008746

Brief Summary

Pseudomonas aeruginosa (PA ) is associated with chronic lung infections in patients with chronic obstructive pulmonary disease (COPD). Commensal flora (microbiota) in lung was recently described using high-throughput sequencing techniques (NGS). PA strains isolated during lung infection episodes of severe COPD patients often show resistance to antibiotics including imipenem that is mainly due to mutation in oprD. In collaboration with Harvard Medical School, the investigators have recently demonstrated that PA OprD mutant shows increased survival (fitness) and its virulence. This bacterium could be more likely to colonize. Colonization by PA OprD mutant could influence the pulmonary microbiota and may worsen disease evolution, particularly in terms of frequency of exacerbations. Our objective is to describe modification of pulmonary microbiota associated with PA colonization, including OprD PA mutant, in severe COPD patients. The investigators will correlate the microbiota modification to medical history. Stable severe COPD patients will be included. Three groups of patients will be sampled: 1) not PA colonized, 2) PA colonized and 3) PA OprD mutant colonized. Medical history will be recorded by the physician as usual and three samples will be performed: 1) sputum, 2) oral wash and 3) water used for oral wash. Regular bacterial culture will be performed and NGS will be performed also to characterize the microbiota.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

January 12, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3.2 years

First QC Date

December 27, 2016

Last Update Submit

May 17, 2022

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

  • Presence of P. aeruginosa resistance to imipenem (OprD mutation)

    12 months

  • Pulmonary microbiota

    12 months

  • questionnaire: the modified Respiratory Medical Council (MMRC)

    12 months

  • St George's respiratory questionnaire

    12 months

Study Arms (3)

not Pseudomonas aeruginosa colonized

EXPERIMENTAL
Other: water used for oral washOther: sputumOther: oral wash

Pseudomonas aeruginosa colonized

EXPERIMENTAL
Other: water used for oral washOther: sputumOther: oral wash

Pseudomonas aeruginosa OprD mutant colonized

EXPERIMENTAL
Other: water used for oral washOther: sputumOther: oral wash

Interventions

water used for oral washOTHER
Pseudomonas aeruginosa OprD mutant colonizedPseudomonas aeruginosa colonizednot Pseudomonas aeruginosa colonized
sputumOTHER
Pseudomonas aeruginosa OprD mutant colonizedPseudomonas aeruginosa colonizednot Pseudomonas aeruginosa colonized
oral washOTHER
Pseudomonas aeruginosa OprD mutant colonizedPseudomonas aeruginosa colonizednot Pseudomonas aeruginosa colonized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe COPD Patients (FEV/FVC\<70% and in FEV\<50% after bronchodilation) hospitalized in the pulmonology Department of the Reims Teaching Hospital.
  • patients who agreed to participate in the study.
  • patients affiliated to a social security scheme.

You may not qualify if:

  • patients \<18yo
  • patients protected by the law.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (2)

  • Audebert C, Even G, Cian A; Blastocystis Investigation Group; Loywick A, Merlin S, Viscogliosi E, Chabe M. Colonization with the enteric protozoa Blastocystis is associated with increased diversity of human gut bacterial microbiota. Sci Rep. 2016 May 5;6:25255. doi: 10.1038/srep25255.

    PMID: 27147260BACKGROUND

  • Wang Z, Bafadhel M, Haldar K, Spivak A, Mayhew D, Miller BE, Tal-Singer R, Johnston SL, Ramsheh MY, Barer MR, Brightling CE, Brown JR. Lung microbiome dynamics in COPD exacerbations. Eur Respir J. 2016 Apr;47(4):1082-92. doi: 10.1183/13993003.01406-2015. Epub 2016 Feb 25.

    PMID: 26917613BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2016

First Posted

January 2, 2017

Study Start

January 12, 2017

Primary Completion

March 9, 2020

Study Completion

May 17, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations

FR(1)