Bacteriophage Effects on Pseudomonas Aeruginosa (MUCOPHAGES)

September 4, 2013 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Languedoc Roussillon
      • Montpellier, Languedoc Roussillon, France, 34295
        • CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Raphaël RC CHIRON, RC, CHU de Montpellier - Hôpital Arnaud de Villeneuve

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 25, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 8750

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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