Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02555059
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2015-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Special Drug Use Investigation of Ciproxan Injection in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D011704', 'term': 'Pyelonephritis'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D000881', 'term': 'Anthrax'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009395', 'term': 'Nephritis, Interstitial'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D011702', 'term': 'Pyelitis'}, {'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': 'D016863', 'term': 'Bacillaceae Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of musculoskeletal adverse events.', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)', 'timeFrame': 'At week 6'}, {'measure': 'Number of participants with adverse events as measure of safety and tolerability', 'timeFrame': 'At week 4'}, {'measure': 'Efficacy', 'timeFrame': 'Up to 2 weeks', 'description': 'Rated by physician with 3-grade scale'}, {'measure': 'Number of participants with adverse events based on abnormal laboratory measurements', 'timeFrame': 'At week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ciprofloxacin', 'Japan', 'Post-marketing surveillance'], 'conditions': ['Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products.'}]}, 'descriptionModule': {'briefSummary': 'The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.', 'detailedDescription': 'This company-sponsored study is an one-arm, prospective, and, cohort-observational study in pediatrics (less than 15 years old) administered Ciproxan injection. All patients in the contracted institute should be enrolled into this study. Consequently 45 cases will be is planned to be enrolled in three-year period Target population is pediatrics with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa. The treatment should be performed based on the product label in Japan. The standard observation will be performed until the last date of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa, are enrolled after the decision for treatment with Ciproxan injection has been made by the investigator.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa.\n* Patients for whom the decision to initiate treatment with Ciproxan injection was made as per investigator's routine treatment practice.\n\nExclusion Criteria:\n\n* N/A"}, 'identificationModule': {'nctId': 'NCT02555059', 'briefTitle': 'Special Drug Use Investigation of Ciproxan Injection in Pediatrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Special Drug Use Investigation of Ciproxan® Injection in Pediatrics', 'orgStudyIdInfo': {'id': '18235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BAYQ3939', 'description': 'Pediatrics patients treated with Ciproxan injection in daily clinical practice.', 'interventionNames': ['Drug: Cipro (Ciprofloxacin, BAYQ3939)']}], 'interventions': [{'name': 'Cipro (Ciprofloxacin, BAYQ3939)', 'type': 'DRUG', 'description': "Treatment parameters following the physician's decision based on the summary of product characteristics.", 'armGroupLabels': ['BAYQ3939']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}