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Bacteriophage Effects on Pseudomonas Aeruginosa (MUCOPHAGES)

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ClinicalTrials.gov Identifier: NCT01818206
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage [ Time Frame: after 6 hours in presence of bacteriophage ]

Secondary Outcome Measures :
  1. Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage [ Time Frame: after 24 hours in presence of bacteriophage ]
  2. Bacteriophage counts after 6 hours incubation within sputum samples [ Time Frame: after 6 hours incubation within sputum samples ]
  3. Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages [ Time Frame: Sensitivity of individual PA colonies to bacteriophages ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818206


Locations
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France
CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM
Montpellier, Languedoc Roussillon, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Raphaël RC CHIRON, RC CHU de Montpellier - Hôpital Arnaud de Villeneuve
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01818206    
Other Study ID Numbers: UF 8750
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013
Keywords provided by University Hospital, Montpellier:
Cystic Fibrosis
Bacteriophages
Pseudomonas aeruginosa
Sputum
Additional relevant MeSH terms:
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Pseudomonas Infections
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections