- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03008746
Pulmonary Microbiota in Patients With Chronic Obstructive Pulmonary Disease Colonized With P. Aeruginosa Resistant to Imipenem (MiPAD)
Pulmonary Microbiota in COPD Patients Colonized With P. Aeruginosa OprD Mutant Resistant to Imipenem
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Reims, France, 51092
- CHU Reims
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: not Pseudomonas aeruginosa colonized
|
|
Experimental: Pseudomonas aeruginosa colonized
|
|
Experimental: Pseudomonas aeruginosa OprD mutant colonized
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of P. aeruginosa resistance to imipenem (OprD mutation)
Time Frame: 12 months
|
12 months
|
Pulmonary microbiota
Time Frame: 12 months
|
12 months
|
questionnaire: the modified Respiratory Medical Council (MMRC)
Time Frame: 12 months
|
12 months
|
St George's respiratory questionnaire
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA16090*
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on water used for oral wash
-
Johnson & Johnson Consumer and Personal Products...Fudan University; Beijing Children's Hospital; Shanghai China-Norm Management... and other collaboratorsCompletedBaby Skin DevelopmentChina
-
AdventHealthCompletedExamination, Gynecological | Examination, Pelvic | Examination, VaginalUnited States
-
Parion SciencesCompletedSjogren's Syndrome | XerostomiaUnited States
-
Al-Azhar UniversityUnknownElectrosurgery Versus Scalpel
-
University of California, San FranciscoNational Eye Institute (NEI); Emory University; The Carter Center; Amhara Public...Recruiting
-
Eunah Cho, MDCompleted
-
International Centre for Diarrhoeal Disease Research...University of California, Berkeley; Stanford UniversityRecruitingChild Development | Maternal DepressionBangladesh
-
Water Pik, Inc.Completed
-
International Centre for Diarrhoeal Disease Research...University of California, Berkeley; Emory University; University of California... and other collaboratorsActive, not recruiting
-
University Hospital, AngersUnknownCoronary Artery Disease | Cardiopulmonary BypassFrance