Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT01400750
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2011-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pseudomonas aeruginosa eradication at the end of the treatment.', 'timeFrame': 'end of study drug treatment ie 3 months for CC and at 1 months for TIS', 'description': 'sucessful eradication is defined as negative airway culture for P aeruginosa and end of study drug which is after 3 months for ciproxin-colistin (CC) and after 1 months for tobramycin for inhalation (TIS)'}], 'secondaryOutcomes': [{'measure': 'P aeruginosa eradication at 6 months after study entry', 'timeFrame': '6 months', 'description': 'negative airway cultures for P aeruginosa up to 6 months after start of study drug'}, {'measure': 'time to new Pa positive culture (= relapse)', 'timeFrame': '1 year', 'description': 'Time to first new P aeruginosa positive airway culture (expressed in months starting from end of study drug)'}, {'measure': 'change from baseline FEV1% pred, IgG z score, BMI z score was followed', 'timeFrame': '1 year', 'description': 'Evolution of lung function (expressed as FEV1% pred), total IgG and nutritional status (expressed as BMI z score) from start of study up to 1 year'}, {'measure': 'Antibody titer for specific anti Pseudomonas antibodies', 'timeFrame': '1 year', 'description': 'Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up'}, {'measure': 'P aeruginosa infection status', 'timeFrame': '1 year', 'description': "P aeruginosa infection status was reported as 'Free off', 'Intermittent' or 'Chronic' according to the Leeds criteria after 1 and 2 years.\n\n(ref Leeds criteria: Lee TW, Brownlee KG, Conway SP, et al. Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. J Cyst Fibros 2003;2(1):29-34)"}, {'measure': 'P aeruginosa infection status', 'timeFrame': '2 years', 'description': "P aeruginosa infection status was reported as 'Free off', 'Intermittent' or 'Chronic' according to the Leeds criteria after 1 and 2 years.\n\n(ref Leeds criteria: Lee TW, Brownlee KG, Conway SP, et al. Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. J Cyst Fibros 2003;2(1):29-34)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cystic fibrosis- P aeruginosa- eradication-child'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '19821321', 'type': 'RESULT', 'citation': 'Langton Hewer SC, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD004197. doi: 10.1002/14651858.CD004197.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.', 'detailedDescription': 'Methods: CF children (0-18 years) with a new isolation of Pa from the airway were randomized to tobramycin inhalation solution (TOBI® 2x300 mg for 28 days) (TIS) or inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) plus oral ciprofloxacin (30mg/kg/day) for 3 months (CC). The primary outcome was eradication at end of treatment. Secondary outcome parameters were time to Pa relapse, total and Pa specific IgG, FEV1, BMI and Pa status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of CF (clinical signs consistent with CF and a sweat chloride \\> 60 mEq/l by quantitative pilocarpine iontophoresis and/or two CF causing mutations identified)\n* age 0 to 18 years old at time of inclusion\n* 'First' or 'new Pa infection' defined as 'first Pa isolation ever' or 'isolation of Pa from the airway (sputum, throat swab or BAL) after a Pa free interval of at least 6 months and documented with at least 3 negative cultures'.\n\nExclusion Criteria:\n\n* chronic Pa infection defined according to the Leeds criteria\\[17\\]\n* pulmonary exacerbation needing IV AB treatment at time of new Pa isolate\n* Pa isolation at time of CF diagnosis\n* patient already on an antipseudomonal antibiotic\n* interval between positive culture and start of treatment \\> 4 weeks."}, 'identificationModule': {'nctId': 'NCT01400750', 'acronym': 'CCTOBI', 'briefTitle': 'Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis.', 'orgStudyIdInfo': {'id': 'MP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ciproxin-inhaled Colistin', 'description': 'oral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months', 'interventionNames': ['Drug: oral ciprofloxacin plus inhaled colistin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobramycine for inhalation (TIS)', 'description': 'tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days', 'interventionNames': ['Drug: TOBI']}], 'interventions': [{'name': 'oral ciprofloxacin plus inhaled colistin', 'type': 'DRUG', 'otherNames': ['Ciproxin ® - ciprofloxacin', 'Colistineb ®'], 'description': 'oral ciprofloxacin (30mg/kg/day divided in 2 doses) for 3 months (CC) plus inhaled colistimethate sodium(Colistineb® 2x2 mill U daily)', 'armGroupLabels': ['Ciproxin-inhaled Colistin']}, {'name': 'TOBI', 'type': 'DRUG', 'otherNames': ['TOBI® - tobramycin inhalation solution (TIS)'], 'description': 'tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days', 'armGroupLabels': ['Tobramycine for inhalation (TIS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Department of pediatrics, CF center Uuiversity Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Marijke J Proesmans, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep pediatrics University Hospital Leuven Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof M Proesmans', 'oldOrganization': 'University Hospital Leuven, dep of pediatrics'}}}}