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Catheter-Related InfectionsPhase 2/3CARCUTINCT02650518

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

A Phase 2/3 study testing Short-course Antibiotics and Catheter Change in people with Catheter-Related Infections, run by National University Hospital, Singapore at 3 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Catheter-Related Infections
What is being tested?
Short-course Antibiotics and Catheter Change
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
3 sitesSingapore
Study dates
Dec 2015to Oct 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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):
Show all 26Show fewer
  • 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
  • Known structural genitourinary abnormalities including:
  • Nephrostomy tubes
  • Tumours of the urinary tract
  • Ureteric stenting
  • Ureteric strictures
  • Urolithiasis
  • Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.
  • Received antibiotics for more than 48 hours prior to randomization.
  • Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.
  • Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.
  • Pregnancy.

Trial locations and contacts

3 sites in 1 country.

Paul A Tambyah, MD contact

paul_anantharajah_tambyah@nuhs.edu.sg

Singapore3 sites, 3 recruiting

  • National University Hospital

    Singapore, 119074

    Paul A Tambyah, MD, paul_anantharajah_tambyah@nuhs.edu.sg

    Paul A Tambyah, MD

    Recruiting

  • Singapore General Hospital

    Singapore, 169608

    Moi Lin Ling, FRCPA, ling.moi.lin@sgh.com.sg

    Moi Lin Ling, FRCPA

    Not yet recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433

    David Lye, FRACP, FAMS, David_LYE@ttsh.com.sg

    David Lye, FRACP, FAMS

    Not yet recruiting

Other trials in Singapore

About this study

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

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.

Being tested
Short-course Antibiotics, Catheter Change
Keywords
Catheter-Associated Urinary Tract Infections, Antimicrobial Stewardship, Short-Course Antimicrobials
Medical subject headings
Catheter-Related Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short-course AntibioticsOther

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

  • Catheter ChangeDevice

    Urinary catheter change once randomization is complete.

Study groups in NCT02650518
Study groupRoleWhat they receive
ControlNo interventionSubject receives the standard of care that is provided by the primary team taking up his/her case.
Catheter change+Short-course AntibioticsExperimentalNot described
Receives: Other: Short-course Antibiotics; Device: Catheter Change

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution

    Resolution of signs and symptoms of CAUTI

    Measured: Day 14 post-randomisation

Secondary outcomes (11)

  1. Short-Term Resolution

    Resolution of signs and symptoms of CAUTI

    Measured: day 3 and day 7 post-randomisation

  2. Recurrence of fever or symptoms

    Measured: 7, 14 and 30 days post randomization

  3. Haemodynamic instability

    Measured: day 14 post randomization

  4. Admission to high dependency or intensive care units

    Measured: 14 days post-randomization

  5. Length of hospitalization

    Measured: 30 days post-randomization

  6. Re-admission

    Measured: Day 30 post-randomization

  7. Secondary Infections

    Measured: 3 months post-randomization

  8. Recurrent Urinary Tract Infections

    Measured: 3 months and 1 year post-randomization

  9. Urologic surgery or procedure

    Measured: 1 year post-randomization

  10. Antimicrobial use and duration

    Measured: 1 month post-randomization

  11. Colonization or infection by antibiotic-resistant organisms

    Measured: 30 days post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650518
Sponsor's protocol ID
2014/00589
Other IDs
2014
Acronym
CARCUTI
Status last verified
Jan 2016
First submitted
30 Dec 2015
Last updated
8 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17577475

  • 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.

    PubMed 768384

  • 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.

    PubMed 18787972

  • 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.

    PubMed 11868889

  • 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.

    PubMed 18559747

  • 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.

    PubMed 20175247

  • 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.

    PubMed 22760715

  • 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.

    PubMed 2012351

  • 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.

    PubMed 18242357

  • 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.

    PubMed 15356779

  • 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.

    PubMed 10992375

  • 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.

    PubMed 24035770

  • 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.

    PubMed 10934078

  • 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.

    PubMed 21569109

  • 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.

    PubMed 10724054

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Short-course Antibiotics and Catheter Change in people with Catheter-Related Infections, run by National University Hospital, Singapore at 3 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paul A Tambyah, MD (paul_anantharajah_tambyah@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution (time frame: Day 14 post-randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02650518, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.

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