The purpose of this pilot study is to determine the optimal timing to replace a catheter in patients with an indwelling catheter and systematic symptoms of an UTI.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the number of days of hospitalization.
Secondary outcome
The secondary endpoints targets the clinical effect and the safety of the
intervention.
The endpoints measuring the clinical effectiveness are *days of fever*
The endpoints measuring the safety of the intervention are patient reported
side effects, registered complications, ICU admissions, death rate, and
recurrence of UTI in 30 days after the intervention.
Background summary
Patients with an indwelling catheter are more likely to develop an urinary
tract infection (UTI) than patients without an indwelling catheter. Because
there is a great difference in the bacteria that cause UTI in patients with or
without catheter, treatment protocol differs between these patients. While
evidence exists for the antibiotic treatment in UTI patients with a catheter,
there is no consensus about how to deal with the catheter itself. One study has
been done to evaluate the effect of replacing the indwelling catheter in
patients with symptomatic UTI. This study showed that replacing the catheter is
favorable to keeping the catheter in situ. The best moment to replace the
catheter remains unclear. At the Deventer Hospital, it is common practice to
replace the indwelling catheter after two days of antibiotics.
The effect of different timing in the replacement of the indwelling catheter
will be examined in this study to optimize the treatment of patients with an
indwelling catheter with symptomatic UTI. Besides the clinical effect we will
evaluate the safety and the microbiological effect of the intervention.
Study objective
The purpose of this pilot study is to determine the optimal timing to replace a
catheter in patients with an indwelling catheter and systematic symptoms of an
UTI.
Study design
Prospective, randomized pilot study
Intervention
Group 1 (intervention group): After inclusion the catheter will be replaced
immediately. Thereafter urine will be drawn from the new catheter for a second
urine culture and antibiotics will be started.
Group 2 (Standard treatment): The catheter will be replaced after two days of
antibiotic treatment.
Study burden and risks
The risk of taking part in this study is very small. We expect side effects and
complications of antibiotics and replacement of the catheter in the
intervention group are the same in comparison with the standard treatment.
It is a small increased risk of developing a bacteremia because the catheter is
removed from an infected environment whit the risk of creating lesions in the
urinary tract. Theoretically there is a small increased risk of recurrence of
UTI, as some pathogens can develop a biofilm on the new catheter. This limits
the concentration of antibiotics that reach the pathogens.
The extent of the burden of taking part in this study is small, because the
intervention does not include extra invasive procedures and does not require
extra time of patients.
A. Deusinglaan 1
Deventer 7416 SE
NL
A. Deusinglaan 1
Deventer 7416 SE
NL
Listed location countries
Age
Inclusion criteria
- Presentation emergency department of the Deventer hospital
- Indwelling catheter >=10 days and indication for replacement of the catheter
- Fever >38,5C
- No other infection found that can be accountable for the fever
- Admission to a ward of DZ
Exclusion criteria
- Antibiotics <24 hours before presentation
- <18 years
- Patient to unstable to wait for the catheter replacement before the start of antibiotics.
Design
Recruitment
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 |
|---|---|
| CCMO | NL64561.075.18 |