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Chronic Obstructive Pulmonary DiseaseMiPADNCT03008746

Pulmonary Microbiota in Patients With Chronic Obstructive Pulmonary Disease Colonized With P. Aeruginosa Resistant to Imipenem

A study testing water used for oral wash, sputum and oral wash in people with Chronic Obstructive Pulmonary Disease, run by CHU de Reims at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
water used for oral wash, sputum and oral wash
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteFrance
Study dates
12 Jan 2017to 17 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Reims

    Reims, 51092

Other trials in France

About this study

Official title: Pulmonary Microbiota in COPD Patients Colonized With P. Aeruginosa OprD Mutant Resistant to Imipenem

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.

Read the detailed description

Patients: Severe COPD Patients (FEV/Forced vital capacity (FVC)<70% and in FEV<50% after bronchodilation) hospitalized in the pulmonology Department of the Reims Teaching Hospital. At the inclusion, patients should be stable. Inclusion of 20 patients needing 100 patients in total will require 24 months.The study of associated factors with colonization to PA and PA mutant OprD will be performed only for patients known to be not PA carrier. Microbiota characterization will be performed on all patients colonized with PA and on non PA colonized patients randomly selected. The analysis of of PA colonization influence on COPD evolution will be done 12 months after sampling for all patients included.

Evaluation criteria:

  • Presence of P. aeruginosa resistance to imipenem (OprD mutation)
  • Pulmonary microbiota: Determination of the bacterial load (total number of bacterium) and bacterial community diversity. Then, Opertional Taxonomic Unit (OTU) relative abundance will be analyzed at phylum, class, order and family level.
  • Factors associated with colonization with PA and PA mutant OprD: antibiotics, corticosteroids, hospitalization during the year preceding the inclusion, severity of COPD, respiratory symptoms of cough and expectoration, exertional dyspnea assessed by questionnaire the modified Respiratory Medical Council (MMRC), co-morbidities.
  • PA porting Influence and PA mutant OprD on changes to 12 months: the number of exacerbation, severity of exacerbations, number of hospitalization, quality of life assessed by the St George's respiratory questionnaire, death, evolution of ventilatory disorders obstructive.

Investigation:

  • Proposal for participation to all eligible patients at a pulmonology consultation
  • If participation of acceptance (signed informed consent form): 3 bacteriological samples: Sputum (usually done), oral wash with water before washing (made specifically for this study). No change in the patient's medical care (treatment, monitoring, etc ...). Clinical Data Collection: criteria for COPD, pulmonary function, dyspnea and sputum symptoms, assessed by the MMRC scale, quality of life assessed by St George's respiratory questionnaire, antibiotic therapy and hospitalization in the previous 12 months . Revaluation 12 months after sampling as part of the regular monitoring of patients (idem as previously). All the samples will be sent to the clinical laboratory of bacteriology (CHU Reims) as usually done for samples: separation of sample into 2 parts: 1 part stored at -80 ° C and 1 part commonly analyzed. Then, patients will be classified as PA or PA non colonized based on sputum analysis. Mutation in oprD will be characterized in a second step to classify patients as PA or PA OprD mutant carriers. Samples of all patients colonized with PA and on non PA colonized patients randomly selected which have been stored at -80°C will be sent to the "PEGASE" plateform of Institut Pasteur de Lille. Characterization of pulmonary microbiota will be performed by high-throughput sequencing on Illumina "MiSeq" allowing to reach 24 million reads in 2x300 bp paired-end.
Being tested
water used for oral wash, sputum, oral wash
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • water used for oral washOther

  • sputumOther

  • oral washOther

Study groups in NCT03008746
Study groupRoleWhat they receive
not Pseudomonas aeruginosa colonizedExperimentalNot described
Receives: Other: water used for oral wash; Other: sputum; Other: oral wash
Pseudomonas aeruginosa colonizedExperimentalNot described
Receives: Other: water used for oral wash; Other: sputum; Other: oral wash
Pseudomonas aeruginosa OprD mutant colonizedExperimentalNot described
Receives: Other: water used for oral wash; Other: sputum; Other: oral wash

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

  2. Pulmonary microbiota

    Measured: 12 months

  3. questionnaire: the modified Respiratory Medical Council (MMRC)

    Measured: 12 months

  4. St George's respiratory questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start12 Jan 2017
  3. Primary completion9 Mar 2020
  4. Study completion17 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008746
Sponsor's protocol ID
PA16090*
Acronym
MiPAD
Status last verified
May 2022
First submitted
27 Dec 2016
Last updated
23 May 2022
Results posted
No

Publications

  • 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.

    PubMed 27147260
  • 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.

    PubMed 26917613

Questions about this trial

What is this clinical trial studying?

A study testing water used for oral wash, sputum and oral wash in people with Chronic Obstructive Pulmonary Disease, run by CHU de Reims at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of P. aeruginosa resistance to imipenem (OprD mutation) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03008746, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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