Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-19 @ 2:49 PM
Study NCT ID:
NCT01694069
Status:
TERMINATED
Last Update Posted:
2022-02-01
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077725', 'term': 'Piperacillin, Tazobactam Drug Combination'}], 'ancestors': [{'id': 'D000078142', 'term': 'Tazobactam'}, {'id': 'D010397', 'term': 'Penicillanic Acid'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010878', 'term': 'Piperacillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctgovadmin@hsc.wvu.edu', 'phone': '304-293-0216', 'title': 'Clinical Trials Compliance Coordinator', 'organization': 'West Virginia Universtiy, WVCTSI'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'The study was terminated and the original PI has left the institution. No adverse event information is available; all efforts were to made to retrieve adverse event information, but efforts were unsuccessful.', 'eventGroups': [{'id': 'EG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Forced Expiratory Volume at One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Baseline, Day 0, and Day 14', 'description': 'FEV1 will be measured upon enrollment (day 0). FEV1 will also be measured at end of therapy (day 14). If FEV1 is available when patient was stable, prior to enrollment, this value will be treated as baseline FEV1. Change in FEV1 will be calculated from baseline (if available) to day 14 and also Day 0 to day 14', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Piperacillin Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Day 3', 'description': 'Serum piperacillin concentration will be measured as follows:\n\n* Intermittent infusion arm: prior to dose (trough), 30 minutes (after completion of infusion), and at 4 hours\n* Continuous infusion arm: collected at the same time as in the intermittent infusion arm', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Time to Next Pulmonary Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Patients will be followed up to 52 weeks from time of enrollment', 'description': 'Patients will be followed for time of next subsequent pulmonary exacerbation for up to 52 weeks after completion of receiving study drug. Next pulmonary exacerbation is defined as requiring admission to a hospital for receipt of I.V. antibiotics because of a diagnosis of pulmonary exacerbation.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Day 0 and day 14', 'description': 'The validated CFQ-R will be administered to patients at time of enrollment at end of therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Change in Sputum Density of Pseudomonas Aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Day 0, day 3, and day 14', 'description': 'Sputum density of Pseudomonas aeruginosa will be determined at enrollment, day 3, and at end of therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Day 0 and day 14', 'description': 'The change in weight will be documented from enrollment to end of therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Time to Defervescence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Day 0 to day 14', 'description': 'Temperature will be taken multiple times daily according to standard of care. If patients present febrile, time until patient is afebrile and remains afebrile for 24 hours will be recorded.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Time to Normalization of White Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Day to day 14', 'description': 'White blood cell (WBC) count will be measured once daily. If patient presents with WBC count greater than 11.0 x 10\\^3/mL, time until patient has WBC less than 11.0 x 10\\^3/mL will be recorded.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}, {'type': 'SECONDARY', 'title': 'Clinical Failure of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}, {'id': 'OG001', 'title': 'Continuous Infusion Piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'timeFrame': 'Day 14', 'description': 'Failure of treatment will be defined as patient needing I.V. antibiotics beyond the 14 days allowed in this study. The primary medical team (along with a blinded investigator) treating the patient will determine whether patient requires additional therapy.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and the original PI has left the institution. No outcome measure results information is available; all efforts were to made to retrieve results information, but efforts were unsuccessful.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Intermittent Infusion piperacillin-tazobactam and Continuous infusion piperacillin-tazobactam were combined into the All Study Participants, because the available study data was not separated into arms.\n\nContinuous infusion piperacillin-tazobactam:\n\nPiperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nContinuous infusion piperacillin-tazobactam:\n\nPiperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was terminated and the original PI has left the institution. Minimal results information is available; all efforts were made to retrieve more results information, but were unsuccessful. The available data does not indicate in which arm the participants were enrolled, therefore all available study data with be entered under All Study Participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Intermittent Infusion piperacillin-tazobactam and Continuous infusion piperacillin-tazobactam were combined into the All Study Participants, because the available study data was not separated into arms.\n\nContinuous infusion piperacillin-tazobactam:\n\nPiperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day\n\nContinuous infusion piperacillin-tazobactam:\n\nPiperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily\n\nPiperacillin-tazobactam combination product: 400 mg/kg/day as either intermittent or continuous infusion'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 8 and 99 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'There was no available information about age of participants outside of that included in the inclusion criteria, indicating participants needed to be at least 8 years old to participate.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The study was terminated and the original PI has left the institution. Minimal results information is available; all efforts were made to retrieve more results information, but were unsuccessful. The available data does not indicate in which arm the participants were enrolled, therefore all available study data with be entered under All Study Participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Recruitment was not sufficient to complete the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2012-09-19', 'resultsFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-28', 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Forced Expiratory Volume at One Second (FEV1)', 'timeFrame': 'Baseline, Day 0, and Day 14', 'description': 'FEV1 will be measured upon enrollment (day 0). FEV1 will also be measured at end of therapy (day 14). If FEV1 is available when patient was stable, prior to enrollment, this value will be treated as baseline FEV1. Change in FEV1 will be calculated from baseline (if available) to day 14 and also Day 0 to day 14'}], 'secondaryOutcomes': [{'measure': 'Piperacillin Serum Concentrations', 'timeFrame': 'Day 3', 'description': 'Serum piperacillin concentration will be measured as follows:\n\n* Intermittent infusion arm: prior to dose (trough), 30 minutes (after completion of infusion), and at 4 hours\n* Continuous infusion arm: collected at the same time as in the intermittent infusion arm'}, {'measure': 'Time to Next Pulmonary Exacerbation', 'timeFrame': 'Patients will be followed up to 52 weeks from time of enrollment', 'description': 'Patients will be followed for time of next subsequent pulmonary exacerbation for up to 52 weeks after completion of receiving study drug. Next pulmonary exacerbation is defined as requiring admission to a hospital for receipt of I.V. antibiotics because of a diagnosis of pulmonary exacerbation.'}, {'measure': 'Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score', 'timeFrame': 'Day 0 and day 14', 'description': 'The validated CFQ-R will be administered to patients at time of enrollment at end of therapy'}, {'measure': 'Change in Sputum Density of Pseudomonas Aeruginosa', 'timeFrame': 'Day 0, day 3, and day 14', 'description': 'Sputum density of Pseudomonas aeruginosa will be determined at enrollment, day 3, and at end of therapy'}, {'measure': 'Change in Weight', 'timeFrame': 'Day 0 and day 14', 'description': 'The change in weight will be documented from enrollment to end of therapy'}, {'measure': 'Time to Defervescence', 'timeFrame': 'Day 0 to day 14', 'description': 'Temperature will be taken multiple times daily according to standard of care. If patients present febrile, time until patient is afebrile and remains afebrile for 24 hours will be recorded.'}, {'measure': 'Time to Normalization of White Blood Cell Count', 'timeFrame': 'Day to day 14', 'description': 'White blood cell (WBC) count will be measured once daily. If patient presents with WBC count greater than 11.0 x 10\\^3/mL, time until patient has WBC less than 11.0 x 10\\^3/mL will be recorded.'}, {'measure': 'Clinical Failure of Treatment', 'timeFrame': 'Day 14', 'description': 'Failure of treatment will be defined as patient needing I.V. antibiotics beyond the 14 days allowed in this study. The primary medical team (along with a blinded investigator) treating the patient will determine whether patient requires additional therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['piperacillin', 'tazobactam', 'pseudomonas aeruginosa', 'cystic fibrosis', 'pulmonary exacerbation', 'continuous infusion', 'beta lactam'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa.\n\nPatients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day.', 'detailedDescription': 'All patients will receive combination therapy to include piperacillin-tazobactam 400 mg/kg/day (based on piperacillin component, actual body weight) not to exceed 16 grams and tobramycin 12 mg/kg/day extended interval dosing (once daily). Patients randomized to the continuous infusion group will receive a one-time loading dose of 100 mg/kg over 30 minutes followed immediately by initiation of the continuous infusion.\n\nOther antibiotics with activity against Pseudomonas aeruginosa are not allowed. Patients may receive an antibiotic for treatment of Staphylococcus aureus if deemed appropriate.\n\nOther treatments for pulmonary exacerbation of cystic fibrosis will be left up to the control of the treating physician. Patients will receive a total of 14 days of therapy. If deemed appropriate, patients may be discharged to home where they will continue to receive blinded treatment via an infusion pump. Patients will be evaluated after completing their 14 day course of antibiotics (end of therapy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of cystic fibrosis\n2. 8 years of age or greater\n3. Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria\n4. Pulmonary exacerbation as defined by Fuchs et al.\n\nExclusion Criteria:\n\n1. Admission for greater than 48 hours prior to enrollment\n2. Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months\n3. Current treatment for allergic bronchopulmonary aspergillosis\n4. Pregnant or breast feeding\n5. History of solid organ transplantation\n6. Renal impairment at time of randomization (\\< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those \\< 18 years of age) or receipt of hemodialysis\n7. Allergy to study medication'}, 'identificationModule': {'nctId': 'NCT01694069', 'acronym': 'PIPE-CF', 'briefTitle': 'Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Continuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '24255'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent Infusion piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day', 'interventionNames': ['Drug: Piperacillin-tazobactam combination product']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous infusion piperacillin-tazobactam', 'description': 'Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily', 'interventionNames': ['Drug: Piperacillin-tazobactam combination product']}], 'interventions': [{'name': 'Piperacillin-tazobactam combination product', 'type': 'DRUG', 'otherNames': ['Zosyn'], 'description': '400 mg/kg/day as either intermittent or continuous infusion', 'armGroupLabels': ['Continuous infusion piperacillin-tazobactam', 'Intermittent Infusion piperacillin-tazobactam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Healthcare', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Lisa Biondo, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}