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NCT Number: NCT01818206

Bacteriophage Effects on Pseudomonas Aeruginosa

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.

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM

Montpellier, Languedoc Roussillon, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: after 6 hours in presence of bacteriophage

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: MUCOPHAGES

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2013
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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