Bacteriophage Effects on Pseudomonas Aeruginosa

NCT01818206 | Completed

• 1 other identifier: UF 8750
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Bacteriophages; Pseudomonas aeruginosa; Sputum

Outcome Measures

Primary Outcomes (1)

• Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage

  after 6 hours in presence of bacteriophage

Secondary Outcomes (3)

• 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

Study Arms (1)

Cystic fibrosis (CF) patients

EXPERIMENTAL

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.

Interventions

Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages. OTHER

Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

Cystic fibrosis (CF) patients

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents
• Law protected patient
• Realisation of sputum production is contra-indicated

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM

Montpellier, Languedoc Roussillon, 34295, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Raphaël RC CHIRON, RC

  CHU de Montpellier - Hôpital Arnaud de Villeneuve

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

FR (1)