Shorter treatment of catheter-related urrinary tract infections

Rationale:

UTI is the most common infection experienced by residents of nursing homes, and the most frequently reported indication for antibiotic prescribing. 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.



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 infection and incidence of C. difficile associated diarrhea.



Study design:

A non-blinded, randomized controlled trial.



Study population:

Patients with a longterm indwelling catheter who develop signs/symptoms of a UTI.



Intervention:

The intervention group will receive 5 days of antibiotic therapy, as compared to 10 days in the control group.



Main study parameters/endpoints:

The primary study endpoint is the recurrence of a symptomatic UTI during 90 days after randomization. Secondary study endpoints are: recurrence of a symptomatic UTI, 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 randomization, resistance pattern of cultured microorganisms after end-of-treatment, total antibiotic consumption, overall and for UTI during 90 days after randomization, acute hospitalizations for infection and C. difficile associated diarrhea during 90 days after randomization.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
After treatment for the UTI, participants will return for 4 short visits to the hospital/rehabilitation centre to hand in a urine sample and a short interview regarding symptoms/complaints of UTI. If patients develop new complaints, they will be asked to contact research physician for evaluation. There is a small risk associated with shorter treatment of CA-UTI, as the non-inferiority yet had to be investigated, although previous studies do not show increased risk associated with shorter treatment. This study will not benefit patients and investigators directly, but will benefit the general community.

Treating a symptomatic urinary tract infection in patients with a long-term indwelling catheter for 5 days is non-inferior compared to the standard duration of 10 days of antibiotic therapy with regard to clinical cure rate.

The primary endpoint is 90 days after randomisation.

Secondary endopoints are up to 180 days after randomisation.

Patients will be treated with antibiotics according to SWAB/Verenso guideline. In the intervention arm, patients will receive 5 days of therapy. In control arm will receive 10 days of antibiotic treatment according to current guideline.



Patients with a indwelling catheter may carry the usual flora, such as Enterobacteriaceae and enterococci, but also Pseudomonas spp., Serratia spp., Providencia spp. and Acinetobacter spp.. Therefore a double-blind trial is not feasible, as the treatment should be tailored to the cultured microorganism.