MUCOPHAGES: Bacteriophage Effects on Pseudomonas Aeruginosa

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT01818206

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

29.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cystic fibrosis (CF) patients Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages.	Other: Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages. Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

Arm

Intervention/Treatment

Experimental: Cystic fibrosis (CF) patients

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

Other: Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts 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