Markers of Pulmonary Dysbiosis Associated With Exacerbation in Patients Followed for Cystic Fibrosis

NCT03569904 | Unknown

• 1 other identifier: 38RC17.317
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim objective is to identify markers of bacterial, viral and fungal pulmonary dysbiosis, associated with the occurrence of exacerbation in patients followed for cystic fibrosis. The primary endpoint is the association between a modification of at least 10% of the relative abundance of a bacterial phylum (Proteobacteria, Firmicutes, Actinobacteria, Bacteroidetes, Fusobacteria) or fungal (ascomycetes / hemiascomycetes, basidiomycetes, zygomycetes), or viral, and the occurrence of exacerbations over a period of 12 months.

Conditions

Cystic Fibrosis Pulmonary Exacerbation

Keywords

Cystic fibrosis; Pulmonary Dysbiosis; pulmonary exacerbation; Fungal bacterial pulmonary dysbiosis; Viral bacterial pulmonary dysbiosis; Microbiota

Outcome Measures

Primary Outcomes (1)

• Identification of markers of bacterial fungal and viral dysbiosis associated with the occurrence of exacerbation in patients followed for cystic fibrosis.

  Association between a modification of at least 10% of the relative abundance of a bacterial phylum (Proteobacteria, Firmicutes, Actinobacteria, Bacteroidetes, Fusobacteria) or fungal (ascomycetes / hemiascomycetes, basidiomycetes, zygomycetes), or viral and the occurrence of exacerbations over a period of 12 months.

  One year

Secondary Outcomes (8)

• Evaluation of the influence of the modification of the relative abundance of different bacterial, viral and fungal taxa, on the occurrence of exacerbations

  One year

• Evaluation of the influence of the global biodiversity of the bacterial and fungal pulmonary microbiome on the occurrence of exacerbations.

  One year

• Association between markers of respiratory function and the relative abundance of different bacterial, viral and fungal phyla and taxa

  One year

• Evaluation of the link between an increase in inflammatory markers and the occurrence of exacerbations

  One year

• Association between markers of respiratory function and serum inflammatory markers

  One year

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients followed for cystic fibrosis are followed in "CRCM". The selection of patients will be done by the various investigating physicians during consultations, day hospitals or admission to the hospital for differents reasons. This research protocol fits as much as possible in the context of routine care, particularly with respect to the rhythmicity of the various visits

You may qualify if:

• Patients with cystic fibrosis
• Patient agreeing to participate in the study
• Patient or legal guardian of the patient able to read and understand the procedure and able to express his / her consent for the study protocol
• Stable patients, away from exacerbation (at 4 weeks from the beginning of exacerbation, found to be resolved by the investigator)
• Patient affiliated to the social security scheme

You may not qualify if:

• Patients who can not read
• Patients opposing the use of their medical data
• Unstable patients, less than one month from the beginning of the exacerbation
• Pregnant or lactating women
• Adult patient under curatorship or tutorship, person deprived of liberty
• Patient awaiting transplant or non-invasive ventilation in chronic
• Patient can not be contacted in case of emergency

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, France

RECRUITING

Related Publications (14)

• Beaumier L, Chanoine S, Camara B, Pison C, Bedouch P. Alemtuzumab and de novo pulmonary arterial hypertension: A potential association? J Heart Lung Transplant. 2017 Mar;36(3):370-371. doi: 10.1016/j.healun.2016.10.013. Epub 2016 Oct 29. No abstract available.

  PMID: 27889369 BACKGROUND

• Wintenberger C, Maubon D, Charpentier E, Rendu J, Pavese P, Augier C, Malvezzi P, Camara B, Mallaret MR, Bouillet L, Epaulard O. Grouped Cases of Pulmonary Pneumocystosis After Solid Organ Transplantation: Advantages of Coordination by an Infectious Diseases Unit for Overall Management and Epidemiological Monitoring. Infect Control Hosp Epidemiol. 2017 Feb;38(2):179-185. doi: 10.1017/ice.2016.274. Epub 2016 Nov 28.

  PMID: 27890037 BACKGROUND

• Zhao Y, Garnaud C, Brenier-Pinchart MP, Thiebaut-Bertrand A, Saint-Raymond C, Camara B, Hamidfar R, Cognet O, Maubon D, Cornet M, Perlin DS. Direct Molecular Diagnosis of Aspergillosis and CYP51A Profiling from Respiratory Samples of French Patients. Front Microbiol. 2016 Jul 29;7:1164. doi: 10.3389/fmicb.2016.01164. eCollection 2016.

  PMID: 27524978 BACKGROUND

• Decorte N, Gruet M, Camara B, Quetant S, Mely L, Vallier JM, Verges S, Wuyam B. Absence of calf muscle metabolism alterations in active cystic fibrosis adults with mild to moderate lung disease. J Cyst Fibros. 2017 Jan;16(1):98-106. doi: 10.1016/j.jcf.2016.05.010. Epub 2016 Jun 15.

  PMID: 27316662 BACKGROUND

• Claustre J, Brion JP, Quetant S, Bedouch P, Pison C, Camara B. Favorable Evolution of Cryptococcal Meningitis in the Context of Flucytosine Resistance. Exp Clin Transplant. 2018 Feb;16(1):110-113. doi: 10.6002/ect.2015.0217. Epub 2016 Apr 26.

  PMID: 27143150 BACKGROUND

• Roca A, Oluwalana C, Bojang A, Camara B, Kampmann B, Bailey R, Demba A, Bottomley C, D'Alessandro U. Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial. Clin Microbiol Infect. 2016 Jun;22(6):565.e1-9. doi: 10.1016/j.cmi.2016.03.005. Epub 2016 Mar 26.

  PMID: 27026482 BACKGROUND

• Godet C, Laurent F, Bergeron A, Ingrand P, Beigelman-Aubry C, Camara B, Cottin V, Germaud P, Philippe B, Pison C, Toper C, Carette MF, Frat JP, Beraud G, Roblot F, Cadranel J; ACHROSCAN Study Group. CT Imaging Assessment of Response to Treatment in Chronic Pulmonary Aspergillosis. Chest. 2016 Jul;150(1):139-47. doi: 10.1016/j.chest.2016.02.640. Epub 2016 Feb 19.

  PMID: 26905365 BACKGROUND

• Dumollard C, Bailly S, Perriot S, Brenier-Pinchart MP, Saint-Raymond C, Camara B, Gangneux JP, Persat F, Valot S, Grenouillet F, Pelloux H, Pinel C, Cornet M. Prospective Evaluation of a New Aspergillus IgG Enzyme Immunoassay Kit for Diagnosis of Chronic and Allergic Pulmonary Aspergillosis. J Clin Microbiol. 2016 May;54(5):1236-42. doi: 10.1128/JCM.03261-15. Epub 2016 Feb 17.

  PMID: 26888904 BACKGROUND

• Godet C, Laurent F, Beraud G, Toper C, Camara B, Philippe B, Germaud P, Cottin V, Beigelman-Aubry C, Khalil A, Blouin P, Pouriel M, Roblot F, Bergeron A, Cadranel J; ACHROSCAN study group. Phenotyping chronic pulmonary aspergillosis by cluster analysis. Eur Respir J. 2015 Nov;46(5):1509-12. doi: 10.1183/13993003.00869-2015. Epub 2015 Sep 17. No abstract available.

  PMID: 26381520 BACKGROUND

• Gruet M, Decorte N, Mely L, Vallier JM, Camara B, Quetant S, Wuyam B, Verges S. Skeletal muscle contractility and fatigability in adults with cystic fibrosis. J Cyst Fibros. 2016 Jan;15(1):e1-8. doi: 10.1016/j.jcf.2015.05.004. Epub 2015 May 29.

  PMID: 26033387 BACKGROUND

• Bouvaist H, Thony F, Jondot M, Camara B, Jais X, Pison C. Balloon pulmonary angioplasty in a patient with chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2014 Sep;23(133):393-5. doi: 10.1183/09059180.00000514. No abstract available.

  PMID: 25176976 BACKGROUND

• Claustre J, Quetant S, Camara B, France M, Schummer G, Bedouch P, Pavese P, Saint Raymond C, Bardy B, Masson D, Roth H, Pison C; Grenoble Lung Transplantation group. Nonspecific immunoglobulin replacement in lung transplantation recipients with hypogammaglobulinemia: a cohort study taking into account propensity score and immortal time bias. Transplantation. 2015 Feb;99(2):444-50. doi: 10.1097/TP.0000000000000339.

  PMID: 25099705 BACKGROUND

• Bosc C, Clement M, Deroux A, Mammar A, Pison C, Camara B. [Severe pneumonia due to cytomegalovirus in chronic obstructive pulmonary disease]. Rev Mal Respir. 2014 May;31(5):435-8. doi: 10.1016/j.rmr.2013.09.013. Epub 2013 Dec 2. French.

  PMID: 24878160 BACKGROUND

• Camara B, Reymond E, Saint-Raymond C, Roth H, Brenier-Pinchart MP, Pinel C, Cadranel J, Ferretti G, Pelloux H, Pison C; Grenoble Aspergillus Committee. Characteristics and outcomes of chronic pulmonary aspergillosis: a retrospective analysis of a tertiary hospital registry. Clin Respir J. 2015 Jan;9(1):65-73. doi: 10.1111/crj.12105. Epub 2014 Feb 17.

  PMID: 24406138 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Boubou CAMARA, Dr

CONTACT

+33(0)4 76 76 58 46; BCamara@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: October 2, 2018
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)