Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections

NCT02650518 | Unknown Phase 2 DMC

• 1 other identifier: 2014/00589
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Catheter-Related Infections

Keywords

Catheter-Associated Urinary Tract Infections; Antimicrobial Stewardship; Short-Course Antimicrobials

Outcome Measures

Primary Outcomes (1)

• Resolution

  Resolution of signs and symptoms of CAUTI

  Day 14 post-randomisation

Secondary Outcomes (11)

• Short-Term Resolution

  day 3 and day 7 post-randomisation

• Recurrence of fever or symptoms

  7, 14 and 30 days post randomization

• Haemodynamic instability

  day 14 post randomization

• Admission to high dependency or intensive care units

  14 days post-randomization

• Length of hospitalization

  30 days post-randomization

Study Arms (2)

Control

NO INTERVENTION

Subject receives the standard of care that is provided by the primary team taking up his/her case.

Catheter change+Short-course Antibiotics

EXPERIMENTAL

Other: Short-course Antibiotics; Device: Catheter Change

Interventions

Short-course Antibiotics OTHER

3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.

Catheter change+Short-course Antibiotics

Catheter Change DEVICE

Urinary catheter change once randomization is complete.

Catheter change+Short-course Antibiotics

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients ≥ 21 years old.
• Presence of indwelling urinary catheter at the time of urine culture for ≥2days.
• Fever \>38°C.
• A urine specimen sent to the hospital microbiological laboratory for culture.
• An antibiotic order for presumed symptomatic catheter associated urinary tract infection.

You may not qualify if:

• Persistent fever \>38°C for more than 24 hours, or any fever \>38.9°C.
• Haemodynamic instability, defined as:
• Requirement for intravenous vasopressor agents
• Systolic blood pressure \<90 mmHg
• Acute hypotensive event with drop in systolic blood pressure of \>30 mmHg or diastolic blood pressure of \>20 mmHg
• The following laboratory values within the previous 48 hours (if available):
• White blood cell count\>15 or \<4 x10\^9/L.
• Procalcitonin\>0.25ug/mL
• C Reactive Protein \>100mg/mL
• An increase in the serum creatinine of more than 50% from baseline
• New requirement for oxygen supplement.
• Current admission to a high dependency unit or ICU.
• Radiological evidence of an upper urinary tract infection
• Flank pain or tenderness, suggesting an upper urinary tract infection
• Urologic surgical procedure within the previous 72 hours

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Tan Tock Seng Hospital: collaborator
• Singapore General Hospital: collaborator
• National University of Singapore: collaborator

Study Sites (3)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

NOT YET RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

NOT YET RECRUITING

Related Publications (18)

• 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: 17577475 BACKGROUND

• 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: 768384 BACKGROUND

• 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: 18787972 BACKGROUND

• 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.

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• 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: 18559747 BACKGROUND

• 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: 20175247 BACKGROUND

• 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: 22760715 BACKGROUND

• 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: 2012351 BACKGROUND

• 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: 18242357 BACKGROUND

• 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: 15356779 BACKGROUND

• 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: 10992375 BACKGROUND

• 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: 24035770 BACKGROUND

• 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.

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  PMID: 21569109 BACKGROUND

• 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.

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MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Paul A Tambyah, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul A Tambyah, MD

CONTACT

paul_anantharajah_tambyah@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 8, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

SG (3)