Bacteriophage Effects on Pseudomonas Aeruginosa

Cystic Fibrosis Clinical Trial

— MUCOPHAGES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818206
• Other study ID #: UF 8750
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: September 4, 2013
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: September 2013
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Infections

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM	Montpellier	Languedoc Roussillon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage		after 6 hours in presence of bacteriophage	No
Secondary	Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage		after 24 hours in presence of bacteriophage	No
Secondary	Bacteriophage counts after 6 hours incubation within sputum samples		after 6 hours incubation within sputum samples	No
Secondary	Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages		Sensitivity of individual PA colonies to bacteriophages	No