Seven vs. 14 Days Treatment for Male Urinary Tract Infection

The proposed study is a randomized placebo-controlled trial of treatment duration for male
urinary tract infection (UTI). Specifically, 319 men with a UTI will be randomized to 7 vs.
14 days of antimicrobial treatment. The primary outcome is resolution of UTI symptoms,
assessed 14 days after completing active antimicrobial treatment. Secondary outcomes include
recurrent UTI in the 4 weeks after treatment, adverse drug events, and intestinal carriage of
antimicrobial resistant Gram-negative bacilli. Subjects will be enrolled from the Primary
Care Clinic and Emergency Department at the Minneapolis VA Medical Center (MVAMC).

Currently, the optimal treatment duration for male UTI is unknown. A clinical trial of 14 vs.
28 days of treatment showed no difference in outcomes, whereas another trial of 3 vs.14 days
showed an increase in recurrence with 3 days of treatment. However, current treatment
recommendations are to treat men with UTI for 7 to 14 days, and no data exist to favor the
shorter or longer duration. Most men with UTI in the VA are treated for more than 7 days,
which is associated with a small but significant increase in Clostridium difficile infection.
Additionally, other studies of non-UTI infectious diseases have shown that longer-duration
treatment leads to increased antimicrobial resistance. Longer-duration treatment is also more
costly and inconvenient to patients. Thus, since longer-duration treatment is associated with
some adverse outcomes, in order to justify longer-duration treatment thee must be some
clinically significant benefit to the extended treatment.

Accordingly, the proposed randomized placebo-controlled trial of 319 men with UTI will test
the hypothesis that 7 days of antimicrobial treatment is non-inferior for the resolution of
UTI symptoms when compared to 14 days of treatment. This study will provide valuable
information to VA patients and clinicians regarding a common and understudied clinical
decision.

Inclusion Criteria:

Must have all

- Male gender

- New-onset (within 7 days) of at least one of the following symptoms/findings: dysuria,
urinary frequency, urgency, hematuria, perineal pain, supra-pubic pain, costovertebral
angle tenderness, or flank pain

- Treated as an outpatient (Primary Care Center or Emergency Department), with < 24
hours observation in the hospital or Emergency Department following the time of
initial diagnosis

- Prescribed treatment with at least 7 days, but not more than 14 days, of either
ciprofloxacin or TMP-SMZ

Exclusion Criteria:

Must have none

- Admission to the hospital (for > 24h) at the time of diagnosis

- Documented fever at time of initial evaluation ( 38.0 Celsius)

- Previous enrollment in the study

- Treatment for UTI in past 14 days

- Not able to give informed consent

- Unwilling to return for study visit

- Symptoms thought more likely to be caused by a non-UTI diagnosis (e.g., urinary
calculus, sexually transmitted infection, etc.)

- Other antimicrobial therapy (new or ongoing) prescribed for a non-UTI diagnosis (e.g.,
cellulitis, pneumonia, etc.)

- Treatment initiated with an empiric antimicrobial to which the organism isolated in
the urine culture is non-susceptible based on standard laboratory criteria

- Treatment initiated with an empiric antimicrobial regimen that is underdosed, based on
current guidelines and reviews