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

Catheter-Related Infections Clinical Trial

— CARCUTI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02650518
• Other study ID #: 2014/00589
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 30, 2015
• Last updated: January 7, 2016
• Start date: December 2015
• Est. completion date: October 2018

Study information

• Verified date: January 2016
• Source: National University Hospital, Singapore
• Contact: Paul A Tambyah, MD
• Email: paul_anantharajah_tambyah[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthoritySingapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Inpatients = 21 years old.

2. Presence of indwelling urinary catheter at the time of urine culture for =2days.

3. Fever >38°C.

4. A urine specimen sent to the hospital microbiological laboratory for culture.

5. An antibiotic order for presumed symptomatic catheter associated urinary tract infection.

Exclusion Criteria:

1. Persistent fever >38°C for more than 24 hours, or any fever >38.9°C.

2. 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

3. 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

4. New requirement for oxygen supplement.

5. Current admission to a high dependency unit or ICU.

6. Radiological evidence of an upper urinary tract infection

7. Flank pain or tenderness, suggesting an upper urinary tract infection

8. Urologic surgical procedure within the previous 72 hours

9. Known structural genitourinary abnormalities including:

• Nephrostomy tubes

• Tumours of the urinary tract

• Ureteric stenting

• Ureteric strictures

• Urolithiasis

10. Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.

11. Received antibiotics for more than 48 hours prior to randomization.

12. Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.

13. Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.

14. Pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheter-Related Infections
• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Other:
• Short-course Antibiotics
3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.

Device:
• Catheter Change
Urinary catheter change once randomization is complete.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore, Singapore General Hospital, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (18)

Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. — View 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. — View 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. — View 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. Epub 2004 Aug 13. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 Singapore. 2012 May;41(5):189-93. — View 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. — View 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. — View 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. — View Citation

Scott IA. Non-inferiority trials: determining whether alternative treatments are good enough. Med J Aust. 2009 Mar 16;190(6):326-30. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution	Resolution of signs and symptoms of CAUTI	Day 14 post-randomisation	Yes
Secondary	Short-Term Resolution	Resolution of signs and symptoms of CAUTI	day 3 and day 7 post-randomisation	Yes
Secondary	Recurrence of fever or symptoms		7, 14 and 30 days post randomization	Yes
Secondary	Haemodynamic instability		day 14 post randomization	Yes
Secondary	Admission to high dependency or intensive care units		14 days post-randomization	Yes
Secondary	Length of hospitalization		30 days post-randomization	No
Secondary	Re-admission		Day 30 post-randomization	Yes
Secondary	Secondary Infections		3 months post-randomization	Yes
Secondary	Recurrent Urinary Tract Infections		3 months and 1 year post-randomization	Yes
Secondary	Urologic surgery or procedure		1 year post-randomization	Yes
Secondary	Antimicrobial use and duration		1 month post-randomization	Yes
Secondary	Colonization or infection by antibiotic-resistant organisms		30 days post-randomization	Yes

External Links

•   Catheter-Associated Urinary Tract Infection (CAUTI) Event (by CDC)