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Bacteriophage Effects on Pseudomonas Aeruginosa (MUCOPHAGES)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Bacteriophages, Pseudomonas aeruginosa, Sputum

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent
  • Affiliated or benefit from a disease insurance regimen
  • Men and women
  • Aged from at least 6 years old
  • Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs.
  • Patients able to produce sputum
  • Pseudomonas aeruginosa Chronic infected patients

Exclusion Criteria:

  • Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents
  • Subjet in exclusion period
  • Law protected patient
  • Realisation of sputum production is contra-indicated

Sites / Locations

  • CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cystic fibrosis (CF) patients

Arm Description

Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

Outcomes

Primary Outcome Measures

Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage

Secondary Outcome Measures

Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage
Bacteriophage counts after 6 hours incubation within sputum samples
Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages

Full Information

First Posted
March 21, 2013
Last Updated
September 4, 2013
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01818206
Brief Title
Bacteriophage Effects on Pseudomonas Aeruginosa
Acronym
MUCOPHAGES
Official Title
Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Bacteriophages, Pseudomonas aeruginosa, Sputum

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cystic fibrosis (CF) patients
Arm Type
Experimental
Arm Description
Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
Intervention Type
Other
Intervention Name(s)
Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
Intervention Description
Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
Primary Outcome Measure Information:
Title
Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage
Time Frame
after 6 hours in presence of bacteriophage
Secondary Outcome Measure Information:
Title
Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage
Time Frame
after 24 hours in presence of bacteriophage
Title
Bacteriophage counts after 6 hours incubation within sputum samples
Time Frame
after 6 hours incubation within sputum samples
Title
Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages
Time Frame
Sensitivity of individual PA colonies to bacteriophages

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent Affiliated or benefit from a disease insurance regimen Men and women Aged from at least 6 years old Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs. Patients able to produce sputum Pseudomonas aeruginosa Chronic infected patients Exclusion Criteria: Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents Subjet in exclusion period Law protected patient Realisation of sputum production is contra-indicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaël RC CHIRON, RC
Organizational Affiliation
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM
City
Montpellier
State/Province
Languedoc Roussillon
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Bacteriophage Effects on Pseudomonas Aeruginosa

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