Send to

Choose Destination
PLoS One. 2018 May 16;13(5):e0197302. doi: 10.1371/journal.pone.0197302. eCollection 2018.

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.

Author information

Department of Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Department of Microbiology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.



To 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.


Hospitalized 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%.


Between 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).


Stopping 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.


Clinical Trials Registry-India; CTRI/2016/04/006810.

[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center