639 - Short Course Therapy for Urinary Tract Infections (SCOUT) in Children

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Presenting Author(s)

TZ

Theoklis Zaoutis

Professor of Pediatrics, Attending Physician
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Co-Author(s)

SB

Sonika Bhatnagar

Associate Professor of Pediatrics
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
SB

Stephen I. Black

Manager, Biostatistics
CHOP - BDMC
Philadelphia, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Susan E. Coffin

Attending Physician
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Kevin J. Downes

Assistant Professor of Pediatrics
Children's Hospital of Philadelphia
Philadelphia, PA
Disclosure: Merck, Inc. (Grant/Research Support)
Brian T. Fisher

Associate Professor of Pediatrics and Epidemiology
Children's Hospital of Philadelphia; Perelman School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania
Disclosure: Astellas (Advisor or Review Panel member)Merck (Grant/Research Support)Pfizer (Grant/Research Support)
Jeffrey Gerber

Associate Professor of Pediatrics
Children's Hospital of Philadelphia
Philadelphia, PA
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Michael D. Green

Professor
University of Pittsburgh School of Medicine
Pittsburgh, PA
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Ebbing Lautenbach

Professor of Medicine and Epidemiology
University of Pennsylvania
Philadelphia, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
KL

Kellie Liston

Clinical Research Coordinator
Children's Hospital of Philadelphia
Philadelphia, PA
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Judith M. Martin

Professor of Pediatrics
University of Pittsburgh
Pittsburgh, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
GM

Gysella Muniz

Assistant Professor
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
SM

Sage R. Myers

Director of Trauma and Resuscitation for Emergency Medicine
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
SO

Shawn O'Connor

Administrative Director
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
ER

Elizabeth Rowley

Senior Biostatistician
Westat
Durham, North Carolina
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
NS

Nader Shaikh

Professor of Pediatrics
University of Pittsburgh
Pittsburgh, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
TS

Timothy Shope

Professor of Pediatrics
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
AH

Alejandro Hoberman

Chief, Division of General Academic Pediatrics
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Background: The AAP recommends 7 to 14-days of antimicrobials for the treatment of urinary tract infections (UTIs), one of the most common bacterial infections of childhood. However, most physicians routinely prescribe at least 10 days of therapy. Prior observational studies suggest that courses shorter than 10 days might be effective.

Methods: The primary objective was to determine if halting antimicrobial therapy in children who improved clinically after 5 days of therapy (short course therapy) results in a similar failure rate as children who continue antimicrobials for an additional 5 days (standard course therapy).

This was a multi-center, randomized, double-blind, placebo-controlled non-inferiority clinical trial of children ages 2 to 10 years with UTI. Subjects treated with 1 of 5 antibiotics (trimethoprim-sulfamethoxazole, amoxicillin-clavulanate, cefixime, cefdinir or cephalexin) were eligible. Children were stratified by presence or absence of fever and were enrolled if they had clinical improvement before Day 5 of treatment. The a priori equivalence interval was set at 0.05 for a one-sided analysis. The primary outcome was development of a symptomatic UTI defined as the presence of symptoms, pyuria, and a positive urine culture. The Intent-to-Treat population included children who took at least one dose of study medication.

Results: A total of 693 children were randomized, 345 to short course and 348 to standard course. Median age was 4 years old (IQR; 2-6), 652 (96.3%) were female and 255 were febrile (37%). Treatment success rate was 322/336 (96%) for short course and 326/328 (99%) for standard course. The 95% upper CI limit for the difference was 0.054. Treatment failure was not related to age group, fever at presentation, antibiotic type, or study site. There were no significant differences between groups the in the rates of adverse events, recurrent infection, clinical symptoms that may have been related to UTI, or emergent antibiotic resistance.

Conclusion: In children aged 2 months to 10 years with UTI, halting antimicrobial therapy in children who had exhibited clinical improvement after 5 days and continuing for an additional 5 days both resulted in high success rates. However, short course was inferior to treatment for 10 days.