Bacteriophage Effects on Pseudomonas Aeruginosa

NCT ID: NCT01818206

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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Cystic Fibrosis Bacteriophages Pseudomonas aeruginosa Sputum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cystic fibrosis (CF) patients

Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphaël RC CHIRON, RC

Role: PRINCIPAL_INVESTIGATOR

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Locations

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CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM

Montpellier, Languedoc Roussillon, France

Site Status

Countries

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France

Other Identifiers

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UF 8750

Identifier Type: -

Identifier Source: org_study_id