The primary objective is to establish the non-inferiority of treating a symptomatic urinary tract infection in patients with a long-term indwelling catheter for 5 days, as compared to the standard duration of 10 days of therapy. Secondary objectives…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the recurrence of a symptomatic UTI during 90
days after end-of-treatment. Relapse and reinfction will be distinguished
according to current guidelines with a modification for patients with a urinary
catheter. Recurrent bacteriuria is defined as eradication of the initial
infecting bacterial species followed by a new episode of bacteriuria after
end-of-treatment; relapse in case of presence of the initial infecting
micro-organism, and reinfection in case of different micro-organism.
Secondary outcome
Secondary study endpoints are: recurrence of a symptomatic UTI during 180 days
after end-of-treatment, time to recurrence of symptomatic UTI, clinical and
microbiological cure at end-of-treatment, results of urine cultures at day 30
and day 90 after end-of-treatment, resistance pattern of cultured
microorganisms after end-of-treatment, total antibiotic consumption (overall
and for UTI) during 90 days after end-of-treatment, acute hospitalizations for
urinary tract infection and C. difficile associated diarrhea during 90 days
after end-of-treatment.
Background summary
Urinary tract infection (UTI) is a very common infection in hospitalized
patients and residents of nursing homes and rehabilitation clinics. It is the
most frequently reported indication for antibiotic prescribing, accounting for
32% to 66% of the prescriptions in nursing homes. Especially patients with a
urinary catheter are at an increased risk. The optimal treatment duration for
symptomatic CA-UTI is unknown. A few small studies suggest that short courses
might be adequate in CA-UTI, but at present the evidence is not conclusive, as
the power and design of these studies are limited. It is desirable to limit the
duration of treatment of CA-UTI to reduce the selection pressure for
drug-resistant flora, especially in patients on long-term catheterization.
Study objective
The primary objective is to establish the non-inferiority of treating a
symptomatic urinary tract infection in patients with a long-term indwelling
catheter for 5 days, as compared to the standard duration of 10 days of
therapy. Secondary objectives are to establish differences between the two
treatment durations in resistance pattern of cultured microorganisms, total
antibiotic consumption (overall and for UTI), incidence of acute
hospitalizations for urinary tract infection and incidence of C. difficile
associated diarrhea, and to gain insight into the accuracy of the modified Loeb
criteria to diagnose catheter-related urinary tract infections.
Study design
A non-blinded, randomized controlled trial with blinded endpoint assesment.
Intervention
The intervention group will receive 5 days of antibiotic therapy, as compared
to 10 days in the control group.
Study burden and risks
After treatment for the UTI, participants will return for 5 short visits to the
hospital/rehabilitation centre to hand in a urine sample and a short interview
regarding symptoms/complaints of UTI. At the end of follow up patients will
have one short interview by telephone. If a patient develops new complaints,
he/she will be asked to contact the research physician for evaluation. There is
a small risk associated with shorter treatment of CA-UTI, as the
non-inferiority is to be investigated, although previous studies do not show an
increased risk associated with shorter treatment. This study will not benefit
patients and investigators directly, but will benefit the general community.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
At presentation with current episode of catheter related urinary tract infection:
1. Indwelling (transurethral or supra-pubic) urinary catheter with the intention for long-term continuous catheterization, at least for the next 28 days
2. Signs/symptoms of a systemic UTI, following the modified Loeb criteria [23,24]: a. patient feels sick. b. at least one of the following signs: Fever > 37.9 ºC; Rigors; New onset delirium; new/worsened costovertebral angle tenderness or other local signs of UTI; In patients with spinal cord injury: increase of spasticity.
3. Positive dipstick leucocyte esterase test, or sediment > 10 leucocytes/mm3. If a dipstick or sediment was not performed, a positive urine is needed.
Exclusion criteria
1. Evidence of acute prostatitis or epididymitis
2. Insufficient understanding of Dutch or English language, or otherwise unable (cognitively impaired or incapacitated) to understand or cooperate in study, or to give informed consent.
3. Patients younger than 18 years of age.
4. Current pregnancy
5. Patients with kidney transplant.
6. Patients with suspected concomitant infection requiring antibiotic treatment
7. Patients with growth of S. aureus or pseudomonas spp in blood culture.
8. Patients that cannot be treated with (combinations of) the following antibiotics: amoxicillin, amoxicillin/clavulanic acid, cefuroxime, cefotaxime, ceftriaxone, ceftazidime, meropenem, gentamicin, tobramycin, ciprofloxacin, cotrimoxazole, vancomycin.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003975-80-NL |
| CCMO | NL63574.018.17 |
| Other | NTR6539 (Nederlands Trial Register) |