Bacteriophage Effects on Pseudomonas Aeruginosa

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

• Registration Number: NCT01818206
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-26
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cystic fibrosis (CF) patients	Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.	Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM; 🇫🇷 Montpellier, Languedoc Roussillon, France