5-Day Versus 10-Day Course of Fluoroquinolones in Outpatient Males With a Urinary Tract Infection (UTI)

Geoffrey A. Mospan, PharmD, BCPS; Kurt A. Wargo, PharmD, FCCP, BCPS (AQ-ID)

Disclosures

J Am Board Fam Med. 2016;29(6):654-662. 

In This Article

Methods

Through the Yale University Open Data Access Project, deidentified, patient-level data were obtained from a previously conducted clinical trial (www.clinicaltrials.gov identifier NCT00210886), a multicenter, double-blind, randomized, noninferiority study comparing levofloxacin 750 mg once daily for 5 days and ciprofloxacin 400 mg IV/500 mg PO twice daily for 10 days in cUTI and acute pyelonephritis.[10] This study was a post hoc, subgroup analysis of male and female subjects with cUTIs only.

Male and female patients at least 18 years old, institutionalized or ambulatory, and diagnosed with a cUTI were included in this study. To be diagnosed with a cUTI, patients had to be male with or without additional complicating factors, or female with at least 1 of the complicating factors listed in Table 1, per the original study protocol.[10] Additional inclusion and exclusion criteria can be found in Table 2. Patients were randomized (1:1) to receive either levofloxacin for 5 days or ciprofloxacin for 10 days. Patients randomized to receive levofloxacin were given a placebo in the evening on days 1 to 5 and a placebo twice daily on days 6 to 10. A urine culture was obtained before administration of the first dose of study medication.

Per the original study protocol, patients were stratified into a modified intent-to-treat population (mITT) if they were randomized to and received at least 1 dose of a study medication, if they were diagnosed with cUTI, and if their culture showed 1 or 2 uropathogens.[10] Patients were further classified as microbiologically evaluable (ME) if they followed the study protocol and were not lost to follow-up.

Patients were evaluated at the end of therapy (EOT), post-therapy (PT), and post-study (PS) to determine clinical success rates[10] (Figure 1). Patients were deemed to achieve clinical success if they were assessed as "clinically cured" (no signs or symptoms of infection and no need for further antimicrobial therapy) or "clinically improved" (signs or symptoms of infection did not completely resolve but no need for further antimicrobial therapy) by the investigator. Patients were defined as a "clinical failure" if any of the following occurred: no response to therapy, worsening or reappearing signs or symptoms of infection, or additional antimicrobial therapy needed.[10]

Figure 1.

Study timeline.

Statistics

Data from the original trial were obtained from the Yale University Open Data Access Project and analyzed in this study using χ2 and Fisher exact tests, with contingency tables for the categorical data of clinical success rates. Statistical significance was established using a 2-tailed α level of 0.05 (SYSTAT 13 version 13.1). Greater than 90% power was achieved in both the mITT and ME groups (males and females) based on the 15% noninferiority margin used by the original study investigators (PASS 14 software; NCSS, Kaysville, UT).[10]

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