Chronic Obstructive Pulmonary Disease Clinical Trial
— MiPADOfficial title:
Pulmonary Microbiota in COPD Patients Colonized With P. Aeruginosa OprD Mutant Resistant to Imipenem
NCT number | NCT03008746 |
Other study ID # | PA16090* |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 12, 2017 |
Est. completion date | May 17, 2022 |
Verified date | May 2022 |
Source | CHU de Reims |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | May 17, 2022 |
Est. primary completion date | March 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - patients <18yo - patients protected by the law. |
Country | Name | City | State |
---|---|---|---|
France | Chu Reims | Reims |
Lead Sponsor | Collaborator |
---|---|
CHU de Reims |
France,
Audebert C, Even G, Cian A; Blastocystis Investigation Group, Loywick A, Merlin S, Viscogliosi E, Chabé 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of P. aeruginosa resistance to imipenem (OprD mutation) | 12 months | ||
Primary | Pulmonary microbiota | 12 months | ||
Primary | questionnaire: the modified Respiratory Medical Council (MMRC) | 12 months | ||
Primary | St George's respiratory questionnaire | 12 months |
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