Stopping the effective non-fluoroquinolone antibiotics at day 7 vs continuing until day 14 in adults with acute pyelonephritis requiring hospitalization: A randomized non-inferiority trial

Abstract

ObjectiveTo evaluate whether stopping the effective antibiotic treatment following clinical improvement at Day 7 (Truncated treatment) would be non-inferior to continued treatment until Day 14 (Continued treatment) in patients with acute pyelonephritis (APN) requiring hospitalization treated with non-fluoroquinolone (non-FQ) antibiotics.MethodsHospitalized adult men and non-pregnant women with culture-confirmed APN were eligible for participation after they had clinically improved following empirical or culture-guided treatment with intravenous non-FQ antibiotic(s). We excluded patients with severe sepsis, abscesses, prostatitis, recurrent or catheter-associated urinary tract infection, or urinary tract obstruction. We randomized eligible patients on Day 7 of effective treatment and assessed them at Weeks 1 and 6 after treatment completion. The primary outcome was retreatment for recurrent urinary tract infection. The prespecified non-inferiority margin was 15%.ResultsBetween March 17, 2015 and August 22, 2016, we randomly allocated 54 patients—27 patients in each arm. Twenty-four (44%) patients were male, and 26 (48%) had diabetes mellitus. Escherichia coli was the most common urinary isolate (47 [87%] patients); 36 (78%) were resistant to ciprofloxacin. In all, 41 (76%) patients received amikacin-based treatment. At the end of 6 weeks, no patient in the truncated treatment arm required retreatment, whereas 1 patient in the continued treatment arm was retreated. Difference (90% CI) in retreatment was −3.7% (−15.01% to 6.15%). Upper bound of the difference (6.15%) was below the prespecified limit, establishing non-inferiority of truncated treatment. Asymptomatic bacteriuria at Week 6 was similar between the two arms (3/24 vs. 3/26; P = 1.0). Patients in the truncated treatment arm had significantly shorter hospital stay (8 [7–10] vs. 14 [14–15] days; P < 0.001) and less antibiotic consumption per patient (8.4 ± 2.8 vs. 17.4 ± 8.3 DDDs; P < 0.001).ConclusionStopping the effective non-FQ antibiotics following clinical improvement at Day 7 is non-inferior to continued treatment until Day 14 in selected patients with APN requiring hospitalization.Trial registrationClinical Trials Registry-India; CTRI/2016/04/006810.

Frequency and clinical significance of prostatic involvement in men with febrile urinary tract infection: a prospective observational study

“…However, clinical cure at 70-84 days did not differ between genders, and shorter treatment did not result in more recurrence in men on long term. Another smaller trial from India comparing non-fluoroquinolone antibiotic therapy for seven or 14 days found no difference in re-treatment rates between males and females 31 . Average antibiotic treatment duration in the present study was less than 10 days.…”

Catheterization Does Not Improve Course of Disease in Female Patients with Acute Cystitis or Pyelonephritis: Retrospective Analysis of &#x3e;300 In-Hospital Treated Patients

“…This observation is quite noteworthy since recent infectious guidelines only recommend vaguely on the duration of antibiotic therapy [10, 13]. It is of note that an EAU guideline cited the study by Rudrabhatla et al [6] investigated that 5 days of intravenous antibiotics are noninferior to 14 days of a combination of intravenous and oral antibiotics in a case series of 54 patients suffering of pyelonephritis. In consequence, the abovementioned risk factors may help to predict prolonged length of antibiotic treatment.…”

“…The European Association of Urology (EAU) infectious guideline addresses in depth the crucial point of antimicrobial therapy for in-hospital treatment of acute cystitis (AC) and pyelonephritis [4]. Fluoroquinolones have been in the center of trials regarding the minimum duration for treating pyelonephritis recently [5, 6]. For example, a shortened intravenous course of fluoroquinolones therapy with 5 days seemed to be noninferior to an intravenous and oral course of fluoroquinolones of 14 days in AC and pyelonephritis patients [5].…”

Guideline of the Swiss Society of Gynaecology and Obstetrics (SSGO) on acute and recurrent urinary tract infections in women, including pregnancy

“…In contrast to previous opinions, asymptomatic diabetic patients should not be treated [31]. In cases of acute pyelonephritis, antibiotic therapy for 7 days has proven to be as effective as the 14 days of therapy used previously [32] (LoE Ib). Complicated UTIs should be treated with a 7-to 10-day antibiotic regimen.…”