Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 3:36 AM
Study NCT ID:
NCT01349192
Status:
TERMINATED
Last Update Posted:
2017-05-15
First Post:
2011-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D007239', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}, {'id': 'D008911', 'term': 'Minocycline'}, {'id': 'D016712', 'term': 'Mupirocin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Marianne_Muhlebach@med.unc.edu', 'phone': '(1) 919 966 1055', 'title': 'Marianne S. Muhlebach, PI', 'organization': 'University of North Carolina, Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was completed prior to reaching the pre-specified number of participants as the Data Safety Monitoring committee observed that efficacy had been reached.'}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Oral antibiotics:\n\nRifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.\n\nTrimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.\n\nPediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.\n\nAlternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.\n\nTopical:\n\nMupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas', 'otherNumAtRisk': 24, 'otherNumAffected': 19, 'seriousNumAtRisk': 24, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Observation', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.', 'otherNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MRSA Culture Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Oral antibiotics:\n\nRifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.\n\nTrimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.\n\nPediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.\n\nAlternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.\n\nTopical:\n\nMupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas'}, {'id': 'OG001', 'title': 'Observation', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.74', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'estimateComment': 'Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.525', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.80', 'pValueComment': 'Test includes adjustment for two interim reviews of efficacy data. The a priori threshold for statistical significance was 0.05.', 'estimateComment': 'Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Proportion of subjects with a negative culture for MRSA at Day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is defined as all of the participants who were randomized to a study arm and were assessed for the primary microbiologic efficacy endpoint at both baseline and Day 28.'}, {'type': 'SECONDARY', 'title': 'Antibiotic Use (Proportion of Subjects)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Oral antibiotics:\n\nRifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.\n\nTrimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.\n\nPediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.\n\nAlternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.\n\nTopical:\n\nMupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas'}, {'id': 'OG001', 'title': 'Observation', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5463', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.34', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'estimateComment': 'Proportion difference was calculated as proportion using antibiotics in the treatment group minus the proportion using antibiotics in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Antibiotic Use (Days of Use Per Subject)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Oral antibiotics:\n\n1. Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.\n2. Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.\n\nPediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.\n\nAlternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.\n\nTopical:\n\nMupirocin: 1 gram 2% nasal ointment twice daily for 14 days.\n\nTopical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.\n\nEnvironmental disinfection of high use areas'}, {'id': 'OG001', 'title': 'Observational', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '44.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.42', 'ciLowerLimit': '-30.3', 'ciUpperLimit': '11.47', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'estimateComment': 'Mean difference was calculated as mean days of antibiotic use in the treatment group minus the mean days of antibiotic use in the observation group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Days of use of oral, inhaled, and IV antibiotics over the 6 month study.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Pulmonary Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Oral antibiotics:\n\nRifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.\n\nTrimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.\n\nPediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.\n\nAlternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.\n\nTopical:\n\nMupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas'}, {'id': 'OG001', 'title': 'Observation', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.03', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'estimateComment': 'Difference was calculated as proportion with a PE treated with MRSA active antibiotics in the treatment group minus the analogous proportion in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Oral antibiotics:\n\n1. Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.\n2. Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.\n\nPediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.\n\nAlternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.\n\nTopical:\n\nMupirocin: 1 gram 2% nasal ointment twice daily for 14 days.\n\nTopical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.\n\nEnvironmental disinfection of high use areas'}, {'id': 'FG001', 'title': 'Observational', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Evaluable for Primary Endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Withdrawals', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Failure to adhere to Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted from April 1, 2011 to September 2014 at 14 CF Foundation accredited care centers in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Oral antibiotics:\n\n1. Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.\n2. Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.\n\nPediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.\n\nAlternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.\n\nTopical:\n\nMupirocin: 1 gram 2% nasal ointment twice daily for 14 days.\n\nTopical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.\n\nEnvironmental disinfection of high use areas'}, {'id': 'BG001', 'title': 'Observational', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '10.5', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '11.5', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': '>=4 and <12 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=12 and <18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'African-American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CF Genotype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Delta F508 Homozygous', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Delta F508 Heterozygous', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unidentified', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'FEV1 Percent of Predicted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98.5', 'spread': '21.6', 'groupId': 'BG000'}, {'value': '101.2', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '99.8', 'spread': '17.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Percent of predicted forced expiratory volume in one second, based on Wang and Hankinson reference equations.', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Lung function was assessed for the subset of participants that were ≥ 6 years old and able to reliably perform spirometry.'}, {'title': 'FEV1 Percent of Predicted Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'categories': [{'title': '>=30% to <=50%', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>50% to <=75%', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>75% to <=100%', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>100%', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Lung function was assessed for the subset of participants that were ≥ 6 years old and able to reliably perform spirometry.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Although this is an open-label study, the PIs and operational study team will remain blinded to the study arm assignments of the aggregate study population and will not view aggregate study results by study arm until after database lock.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'Interim review showed a statistically significant treatment effect and the DMC recommended that the study be stopped with ongoing follow-up of enrolled subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2011-05-04', 'resultsFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2011-05-05', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-05', 'studyFirstPostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRSA Culture Status', 'timeFrame': 'Day 28', 'description': 'Proportion of subjects with a negative culture for MRSA at Day 28.'}], 'secondaryOutcomes': [{'measure': 'Antibiotic Use (Proportion of Subjects)', 'timeFrame': '6 months', 'description': 'Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.'}, {'measure': 'Antibiotic Use (Days of Use Per Subject)', 'timeFrame': '6 months', 'description': 'Days of use of oral, inhaled, and IV antibiotics over the 6 month study.'}, {'measure': 'Pulmonary Exacerbations', 'timeFrame': '28 days', 'description': 'Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MRSA', 'Cystic Fibrosis', 'Early Infection', 'Treatment'], 'conditions': ['Cystic Fibrosis', 'Methicillin-resistant Staphylococcus Aureus']}, 'referencesModule': {'references': [{'pmid': '36511181', 'type': 'DERIVED', 'citation': 'Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.'}, {'pmid': '27852955', 'type': 'DERIVED', 'citation': 'Muhlebach MS, Beckett V, Popowitch E, Miller MB, Baines A, Mayer-Hamblett N, Zemanick ET, Hoover WC, VanDalfsen JM, Campbell P, Goss CH; STAR-too study team. Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial. Thorax. 2017 Apr;72(4):318-326. doi: 10.1136/thoraxjnl-2016-208949. Epub 2016 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA.\n\nParticipants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit.\n\nProcedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.', 'detailedDescription': 'The STAR-too study is a randomized, open label, multi-center study in CF patients with new MRSA isolated from the respiratory tract (sputum or oropharyngeal (OP) swab). The purpose of the study is to compare use of a two week eradication treatment protocol to an observational group treated for MRSA only when respiratory symptoms meet the criteria for a protocol defined pulmonary exacerbation during the first 28 days of the study. A total of 90 participants, four years of age or older, with new MRSA infection are planned to be randomized in a 1:1 fashion to either the treatment arm or to the observational control arm. Randomization is stratified by age, P. aeruginosa status at screening and site. Each participant randomized to the treatment arm receives two oral antibiotics for 14 days, topical antibacterial treatment of skin and nares, and a three week environmental decontamination for high risk areas and equipment. Each participant randomized to the observational control arm is followed clinically with usual care except to treat new or worsening pulmonary symptoms with antibiotics between screening and Day 28 only when participant meets criteria for a protocol defined exacerbation. Participants continue in the study for 6 months with study visits at Day 84 and Day 168 corresponding with their normal quarterly visits, this extension of observation provides additional data regarding natural history of MRSA infection and durability of the eradication protocol. The primary outcome is the proportion of participants with MRSA eradicated from respiratory tract cultures at Day 28. The secondary outcomes number of, and time to, pulmonary exacerbations, and use of antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female ≥ 4 and ≤ 45 years of age at the Screening Visit.\n2. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:\n\n * sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)\n * two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene\n * Abnormal nasal potential difference (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)\n3. First OR early repeat MRSA colonization defined as:\n\n * First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening\n * OR Early repeat MRSA colonization:\n\n MRSA was previously isolated from the respiratory tract (≤ 2 times), but this was followed by at least 1 year of documented negative cultures for MRSA as noted below:\n\n \\-- At least 2 cultures performed at least 3 months apart to document 1 year of culture negativity. Each of these cultures should be documented to have been collected at least 1 week after end of any antibiotic prescription with MRSA activity.\n\n Patient again recently positive for MRSA from the respiratory tract (within 6 months prior to screening)\n4. Clinically stable with no significant changes in health status within the 14 days prior to screening\n5. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study\n\nA repeat culture from the respiratory tract is obtained at screening but does not have to be positive to be able to enter the study.\n\nExclusion Criteria:\n\n1. Received antibiotics with activity against MRSA within 28 days prior to screening (see study manual for list of antibiotics)\n2. Use of an investigational agent within 28 days prior to screening\n3. For subjects ≥ 6 years of age: FEV1 at screening \\< 30% of predicted for age based on the Wang (males \\< 18 years, females \\< 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations\n4. MRSA from the screening culture resistant to rifampin OR resistant to both TMP/SMX and minocycline\n5. History of intolerance to oral rifampin, or topical chlorhexidine or mupirocin\n6. History of intolerance to both TMP/SMX and minocycline\n7. \\< 8 years of age and either allergic or intolerant to TMP/SMX or screening MRSA resistant to TMP/SMX\n8. ≥ 8 years of age and allergic or intolerant to TMP/SMX and screening MRSA resistant to minocycline\n9. ≥ 8 years of age and allergic or intolerant to minocycline and screening MRSA resistant to TMP/SMX\n10. For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 15 of the study\n11. Abnormal renal function at Screening, defined as estimated creatinine clearance \\<50 mL/min using the Cockcroft-Gault equation\n12. Abnormal liver function at the time of screening, defined as ≥2x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT)\n13. History of solid organ or hematological transplantation\n14. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data."}, 'identificationModule': {'nctId': 'NCT01349192', 'acronym': 'STAR-Too', 'briefTitle': 'Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)', 'orgStudyIdInfo': {'id': 'STAR-too-10K0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects are treated with two oral antibiotics, topical antibiotics, and are instructed to use environmental decontamination techniques.', 'interventionNames': ['Drug: Rifampin', 'Drug: Trimethoprim/Sulfamethoxazole', 'Drug: Minocycline', 'Drug: Mupirocin', 'Drug: chlorhexidine gluconate oral rinse', 'Drug: 2% Chlorhexidine solution wipes', 'Behavioral: Environmental Decontamination']}, {'type': 'NO_INTERVENTION', 'label': 'Observational', 'description': 'Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.'}], 'interventions': [{'name': 'Rifampin', 'type': 'DRUG', 'otherNames': ['Rifadin, Rimactane'], 'description': 'Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \\<40kg : 15mg/kg daily for 14 days divided every 12 hours.', 'armGroupLabels': ['Treatment']}, {'name': 'Trimethoprim/Sulfamethoxazole', 'type': 'DRUG', 'otherNames': ['Bactrim, Septra'], 'description': 'Adult Dose: 320/1600 orally twice daily for 14 days. Pediatric Dose: \\<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.', 'armGroupLabels': ['Treatment']}, {'name': 'Minocycline', 'type': 'DRUG', 'otherNames': ['Cleeravue-M, Dynacin, Minocin, Myrac, Solodyn, Vectrin'], 'description': 'only subjects greater or equal to 8 years of age, who are not able to tolerate TMP/SMX or whose screening MRSA is resistant to TMP/SMX should be prescribed minocycline.\n\nAdult dose: 100 mg orally twice daily for 14 days Pediatric dose: \\< 50 kg : 2mg/kg orally twice daily for 14 days not to exceed 200mg per day.', 'armGroupLabels': ['Treatment']}, {'name': 'Mupirocin', 'type': 'DRUG', 'otherNames': ['Bactroban, Centany'], 'description': '1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days.', 'armGroupLabels': ['Treatment']}, {'name': 'chlorhexidine gluconate oral rinse', 'type': 'DRUG', 'description': 'for subjects able to swish without swallowing. 0.12% chlorhexidine gluconate oral rinse twice daily for 14 days.', 'armGroupLabels': ['Treatment']}, {'name': '2% Chlorhexidine solution wipes', 'type': 'DRUG', 'description': 'whole body wash solution wipes once daily for first 5 days.', 'armGroupLabels': ['Treatment']}, {'name': 'Environmental Decontamination', 'type': 'BEHAVIORAL', 'otherNames': ['Sani-Cloth Plus'], 'description': 'wipe down high touch surfaces and medical equipment with surface disinfecting wipes daily for the first 21 days.\n\nwash all linens and towels in hot water once weekly for three weeks.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "The Children's Hospital-University of Birmingham", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '48109-5212', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota Minneapolis", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': "N.C Memorial Hospital and N.C Children's Hospital", 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45229-3026', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98145-9807', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Marianne S Muhlebach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UNC Children's Hospital"}, {'name': 'Chris Goss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'CF Therapeutics Development Network Coordinating Center', 'class': 'NETWORK'}, {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': "Cook Children's Medical Center", 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': "St. Louis Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Pediatric Pulmonolgy', 'investigatorFullName': 'Marianne Muhlebach, MD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}