Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02650518
Status:
UNKNOWN
Last Update Posted:
2016-01-08
First Post:
2015-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2016-01-07', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution', 'timeFrame': 'Day 14 post-randomisation', 'description': 'Resolution of signs and symptoms of CAUTI'}], 'secondaryOutcomes': [{'measure': 'Short-Term Resolution', 'timeFrame': 'day 3 and day 7 post-randomisation', 'description': 'Resolution of signs and symptoms of CAUTI'}, {'measure': 'Recurrence of fever or symptoms', 'timeFrame': '7, 14 and 30 days post randomization'}, {'measure': 'Haemodynamic instability', 'timeFrame': 'day 14 post randomization'}, {'measure': 'Admission to high dependency or intensive care units', 'timeFrame': '14 days post-randomization'}, {'measure': 'Length of hospitalization', 'timeFrame': '30 days post-randomization'}, {'measure': 'Re-admission', 'timeFrame': 'Day 30 post-randomization'}, {'measure': 'Secondary Infections', 'timeFrame': '3 months post-randomization'}, {'measure': 'Recurrent Urinary Tract Infections', 'timeFrame': '3 months and 1 year post-randomization'}, {'measure': 'Urologic surgery or procedure', 'timeFrame': '1 year post-randomization'}, {'measure': 'Antimicrobial use and duration', 'timeFrame': '1 month post-randomization'}, {'measure': 'Colonization or infection by antibiotic-resistant organisms', 'timeFrame': '30 days post-randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Catheter-Associated Urinary Tract Infections', 'Antimicrobial Stewardship', 'Short-Course Antimicrobials'], 'conditions': ['Catheter-Related Infections']}, 'referencesModule': {'references': [{'pmid': '17577475', 'type': 'BACKGROUND', 'citation': 'Edwards JR, Peterson KD, Andrus ML, Tolson JS, Goulding JS, Dudeck MA, Mincey RB, Pollock DA, Horan TC; NHSN Facilities. National Healthcare Safety Network (NHSN) Report, data summary for 2006, issued June 2007. Am J Infect Control. 2007 Jun;35(5):290-301. doi: 10.1016/j.ajic.2007.04.001. No abstract available.'}, {'pmid': '768384', 'type': 'BACKGROUND', 'citation': 'Schaberg DR, Weinstein RA, Stamm WE. Epidemics of nosocomial urinary tract infection caused by multiply resistant gram-negative bacilli: epidemiology and control. J Infect Dis. 1976 Mar;133(3):363-6. doi: 10.1093/infdis/133.3.363. No abstract available.'}, {'pmid': '18787972', 'type': 'BACKGROUND', 'citation': 'Milan PB, Ivan IM. Catheter-associated and nosocomial urinary tract infections: antibiotic resistance and influence on commonly used antimicrobial therapy. Int Urol Nephrol. 2009;41(3):461-4. doi: 10.1007/s11255-008-9468-y. Epub 2008 Sep 12.'}, {'pmid': '11868889', 'type': 'BACKGROUND', 'citation': 'Tambyah PA, Knasinski V, Maki DG. The direct costs of nosocomial catheter-associated urinary tract infection in the era of managed care. Infect Control Hosp Epidemiol. 2002 Jan;23(1):27-31. doi: 10.1086/501964.'}, {'pmid': '18559747', 'type': 'BACKGROUND', 'citation': 'Wald HL, Ma A, Bratzler DW, Kramer AM. Indwelling urinary catheter use in the postoperative period: analysis of the national surgical infection prevention project data. Arch Surg. 2008 Jun;143(6):551-7. doi: 10.1001/archsurg.143.6.551.'}, {'pmid': '20175247', 'type': 'BACKGROUND', 'citation': 'Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. doi: 10.1086/650482.'}, {'pmid': '22760715', 'type': 'BACKGROUND', 'citation': 'Ng E, Earnest A, Lye DC, Ling ML, Ding Y, Hsu LY. The excess financial burden of multidrug resistance in severe gram-negative infections in Singaporean hospitals. Ann Acad Med Singap. 2012 May;41(5):189-93.'}, {'pmid': '2012351', 'type': 'BACKGROUND', 'citation': 'Harding GK, Nicolle LE, Ronald AR, Preiksaitis JK, Forward KR, Low DE, Cheang M. How long should catheter-acquired urinary tract infection in women be treated? A randomized controlled study. Ann Intern Med. 1991 May 1;114(9):713-9. doi: 10.7326/0003-4819-114-9-713.'}, {'pmid': '18242357', 'type': 'BACKGROUND', 'citation': 'Peterson J, Kaul S, Khashab M, Fisher AC, Kahn JB. A double-blind, randomized comparison of levofloxacin 750 mg once-daily for five days with ciprofloxacin 400/500 mg twice-daily for 10 days for the treatment of complicated urinary tract infections and acute pyelonephritis. Urology. 2008 Jan;71(1):17-22. doi: 10.1016/j.urology.2007.09.002.'}, {'pmid': '15356779', 'type': 'BACKGROUND', 'citation': 'Dow G, Rao P, Harding G, Brunka J, Kennedy J, Alfa M, Nicolle LE. A prospective, randomized trial of 3 or 14 days of ciprofloxacin treatment for acute urinary tract infection in patients with spinal cord injury. Clin Infect Dis. 2004 Sep 1;39(5):658-64. doi: 10.1086/423000. Epub 2004 Aug 13.'}, {'pmid': '10992375', 'type': 'BACKGROUND', 'citation': 'Raz R, Schiller D, Nicolle LE. Chronic indwelling catheter replacement before antimicrobial therapy for symptomatic urinary tract infection. J Urol. 2000 Oct;164(4):1254-8.'}, {'pmid': '24035770', 'type': 'BACKGROUND', 'citation': 'Darouiche RO, Al Mohajer M, Siddiq DM, Minard CG. Short versus long course of antibiotics for catheter-associated urinary tract infections in patients with spinal cord injury: a randomized controlled noninferiority trial. Arch Phys Med Rehabil. 2014 Feb;95(2):290-6. doi: 10.1016/j.apmr.2013.09.003. Epub 2013 Sep 11.'}, {'pmid': '10934078', 'type': 'BACKGROUND', 'citation': 'Singh N, Rogers P, Atwood CW, Wagener MM, Yu VL. Short-course empiric antibiotic therapy for patients with pulmonary infiltrates in the intensive care unit. A proposed solution for indiscriminate antibiotic prescription. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):505-11. doi: 10.1164/ajrccm.162.2.9909095.'}, {'pmid': '21569109', 'type': 'BACKGROUND', 'citation': 'Hamasuna R, Takahashi S, Yamamoto S, Arakawa S, Yanaihara H, Ishikawa S, Matsumoto T. Guideline for the prevention of health care-associated infection in urological practice in Japan. Int J Urol. 2011 Jul;18(7):495-502. doi: 10.1111/j.1442-2042.2011.02769.x. Epub 2011 May 16.'}, {'pmid': '10724054', 'type': 'BACKGROUND', 'citation': 'Tambyah PA, Maki DG. Catheter-associated urinary tract infection is rarely symptomatic: a prospective study of 1,497 catheterized patients. Arch Intern Med. 2000 Mar 13;160(5):678-82. doi: 10.1001/archinte.160.5.678.'}, {'pmid': '21546623', 'type': 'BACKGROUND', 'citation': 'Corey GR, Stryjewski ME. New rules for clinical trials of patients with acute bacterial skin and skin-structure infections: do not let the perfect be the enemy of the good. Clin Infect Dis. 2011 Jun;52 Suppl 7:S469-76. doi: 10.1093/cid/cir162.'}, {'pmid': '7160191', 'type': 'BACKGROUND', 'citation': 'Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1.'}, {'pmid': '19296815', 'type': 'BACKGROUND', 'citation': 'Scott IA. Non-inferiority trials: determining whether alternative treatments are good enough. Med J Aust. 2009 Mar 16;190(6):326-30. doi: 10.5694/j.1326-5377.2009.tb02425.x.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: A short course (3-5 days) of antibiotic therapy (experimental arm) is as safe and effective as a long course of antibiotic therapy for the treatment of catheter-associated urinary tract infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inpatients ≥ 21 years old.\n2. Presence of indwelling urinary catheter at the time of urine culture for ≥2days.\n3. Fever \\>38°C.\n4. A urine specimen sent to the hospital microbiological laboratory for culture.\n5. An antibiotic order for presumed symptomatic catheter associated urinary tract infection.\n\nExclusion Criteria:\n\n1. Persistent fever \\>38°C for more than 24 hours, or any fever \\>38.9°C.\n2. Haemodynamic instability, defined as:\n\n * Requirement for intravenous vasopressor agents\n * Systolic blood pressure \\<90 mmHg\n * Acute hypotensive event with drop in systolic blood pressure of \\>30 mmHg or diastolic blood pressure of \\>20 mmHg\n3. The following laboratory values within the previous 48 hours (if available):\n\n * White blood cell count\\>15 or \\<4 x10\\^9/L.\n * Procalcitonin\\>0.25ug/mL\n * C Reactive Protein \\>100mg/mL\n * An increase in the serum creatinine of more than 50% from baseline\n4. New requirement for oxygen supplement.\n5. Current admission to a high dependency unit or ICU.\n6. Radiological evidence of an upper urinary tract infection\n7. Flank pain or tenderness, suggesting an upper urinary tract infection\n8. Urologic surgical procedure within the previous 72 hours\n9. Known structural genitourinary abnormalities including:\n\n * Nephrostomy tubes\n * Tumours of the urinary tract\n * Ureteric stenting\n * Ureteric strictures\n * Urolithiasis\n10. Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.\n11. Received antibiotics for more than 48 hours prior to randomization.\n12. Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.\n13. Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.\n14. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT02650518', 'acronym': 'CARCUTI', 'briefTitle': 'Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections (CARCUTI)', 'orgStudyIdInfo': {'id': '2014/00589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subject receives the standard of care that is provided by the primary team taking up his/her case.'}, {'type': 'EXPERIMENTAL', 'label': 'Catheter change+Short-course Antibiotics', 'interventionNames': ['Other: Short-course Antibiotics', 'Device: Catheter Change']}], 'interventions': [{'name': 'Short-course Antibiotics', 'type': 'OTHER', 'description': '3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.', 'armGroupLabels': ['Catheter change+Short-course Antibiotics']}, {'name': 'Catheter Change', 'type': 'DEVICE', 'description': 'Urinary catheter change once randomization is complete.', 'armGroupLabels': ['Catheter change+Short-course Antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Paul A Tambyah, MD', 'role': 'CONTACT', 'email': 'paul_anantharajah_tambyah@nuhs.edu.sg'}, {'name': 'Paul A Tambyah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Moi Lin Ling, FRCPA', 'role': 'CONTACT', 'email': 'ling.moi.lin@sgh.com.sg'}, {'name': 'Moi Lin Ling, FRCPA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'David Lye, FRACP, FAMS', 'role': 'CONTACT', 'email': 'David_LYE@ttsh.com.sg'}, {'name': 'David Lye, FRACP, FAMS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Paul A Tambyah, MD', 'role': 'CONTACT', 'email': 'paul_anantharajah_tambyah@nuhs.edu.sg'}], 'overallOfficials': [{'name': 'Paul A Tambyah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, {'name': 'Singapore General Hospital', 'class': 'OTHER'}, {'name': 'National University of Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}