Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-09 @ 10:45 AM
Study NCT ID:
NCT01818206
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacteriophage Effects on Pseudomonas Aeruginosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D011552', 'term': 'Pseudomonas Infections'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-04', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage', 'timeFrame': 'after 6 hours in presence of bacteriophage'}], 'secondaryOutcomes': [{'measure': 'Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage', 'timeFrame': 'after 24 hours in presence of bacteriophage'}, {'measure': 'Bacteriophage counts after 6 hours incubation within sputum samples', 'timeFrame': 'after 6 hours incubation within sputum samples'}, {'measure': 'Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages', 'timeFrame': 'Sensitivity of individual PA colonies to bacteriophages'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'Bacteriophages', 'Pseudomonas aeruginosa', 'Sputum'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Affiliated or benefit from a disease insurance regimen\n* Men and women\n* Aged from at least 6 years old\n* 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.\n* Patients able to produce sputum\n* Pseudomonas aeruginosa Chronic infected patients\n\nExclusion Criteria:\n\n* Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents\n* Subjet in exclusion period\n* Law protected patient\n* Realisation of sputum production is contra-indicated'}, 'identificationModule': {'nctId': 'NCT01818206', 'acronym': 'MUCOPHAGES', 'briefTitle': 'Bacteriophage Effects on Pseudomonas Aeruginosa', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients', 'orgStudyIdInfo': {'id': 'UF 8750'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cystic fibrosis (CF) patients', 'description': 'Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages.', 'interventionNames': ['Other: Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.']}], 'interventions': [{'name': 'Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.', 'type': 'OTHER', 'description': 'Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.', 'armGroupLabels': ['Cystic fibrosis (CF) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Languedoc Roussillon', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Raphaël RC CHIRON, RC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Montpellier - Hôpital Arnaud de Villeneuve'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}