Exploring prophylactic co-trimoxazole regimens at the removal of temporary catheters to prevent urinary tract infections: a randomised placebo controlled pilot study

Short-term catherisation is widely applied in a hospital setting. All patients
with a urinary tract catheter develop bacteriuria in time. The catheter creates
a port of entry for micro-organisms and the mechanical wash-out of bacteria by
urine stream is interrupted. The prevalence of this bacteriuria is 3 tot 7 %
per catherisation day. An asymptomatic bacteriuria mostly resolves
spontaneously within 14 days after catheter removal. Asymptomatic bacteriuria
after short term catheter use becomes symptomatic in 15% of the patients within
48 hours.
A questionnaire sent to healthcare professionals in the United Kingdom revealed
that 60% advocated the use of prophylactic antibiotics at the withdrawal of
catheters in all or selected groups of patients. In contrast, a restrictive
policy for the prescription of antibiotics is followed in the Netherlands
compared with other countries in Europe. This low consumption of antibiotics
correlates with relatively low resistance to antibiotics. The restrictive
antibiotic policy and a lack of evidence explains, that routine antibiotic
prophylaxis at the removal of urinary tract catheters is not recommended in the
Dutch guidelines. In contrast urinary tract infections increase costs and
morbidity of patients substantially. The usefulness of antibiotic prophylaxis
was therefore investigated in some studies.
Results of a small randomised double-blind placebo controlled pilot study with
ciprofloxacin at 500mg, twice a day and four doses did not support the benefit
of prophylactic ciprofloxacin to reduce the rate of urinary tract infections.
In a second study, ciprofloxacin at 500mg, twice a day, and six doses was
compared with no antibiotic treatment after laparoscopic radical prostatectomy.
The results of this study demonstrated significant benefit of ciprofloxacin.
Results of a study including female patients only did not indicate a
significant decrease of bacteriuria after treatment with a single dose compared
with a ten days treatment of co-trimoxazole (trimethoprim-sulfamethoxazole) at
1600/320mg once and 800/160mg twice a day. In an other randomized prospective
study a significant benefit of trimethoprim-sulfamethoxazole at 800/160mg twice
a day and three doses was demonstrated in elective abdominal surgery patients.
The results of the studies do not unequivocally advocate antibiotic
prophylaxis. In addition, the experimental set-up differed considerably among
the studies hampering the set-up of a large clinical trial to demonstrate the
efficacy of antibiotic prophylaxis. Here, we explore antibiotic prophylaxis
further in a pilot study. We choose trimethoprim-sulfamethoxazole as
investigational medical product as it may be used in man and woman. In addition
it is effective against a broad range of micro-organisms. Our goal is to
determine a dosing regimen of co-trimoxazole suitable for testing in a future
larger clinical trial to determine the efficacy of antibiotic prophylaxis in
patients with a temporary urinary tract catheter.

To determine a suitable co-trimoxazole regimen for testing in a future larger
clinical trial to determine the efficacy of antibiotic prophylaxis in patients
with a temporary urinary tract catheter.

Doubleblind placebo-controlled three arms pilot intervention study

Trimethoprim-sulfamethoxazole or placebo.

All patients in this trial will have to collect some urine samples.
In addition the occurrence of an urinary tract infection in time will be
examined by using a short questionnaire. The estimated time of filling out the
questionnaire is 5 minutes.
Subjects in the trimethoprim-sulfamethoxazole intervention groups have a risk
of side effects of the IMP depending on the intervention group they are
included, but there is probably a lower risk of urinary tract infections and
resulting complications of these.
Patients in the placebo group have no risk of side effects due to
co-trimoxazole but have probably a higher risk of urinary tract infections and
complications.
Trimethoprim-sulfamethoxazole is an antibiotic which is registered in 1972.
Allergic reactions like exanthema are the most frequently reported side
effects. In case of allergy the medication will be discontinued. The IMP has
common side effect like hyperkalemia, hyponatremia nausea, diarrhoea and
vomiting.