Bacteriophage Effects on Pseudomonas Aeruginosa

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystic fibrosis (CF) patients<br>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.<br>* Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage |  | after 6 hours in presence of bacteriophage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Bacteriophages, Pseudomonas aeruginosa, Sputum