David H. Rubin, MD Chairman and Program Director, Pediatrics St Barnabas Hospital

1. Journal Club/July 31, 2009. Dore-Bergeron et al. Urinary tract infections in 1-3 month old infants: ambulatory treatment with intravenous antibiotics David H. Rubin, MD Chairman and Program Director, Pediatrics St Barnabas Hospital Professor of Clinical Pediatrics, Albert Einstein College of Medicine

2. OBJECTIVES OF SEMINAR • Aim • Hypothesis • Methods and statistical strategies • Conclusion • Competency based evaluation

3. COMPETENCY BASED EVALUATION • Review of competencies (pre-review of article) • Review of competencies (post-review of article) • Application of specific issues from article to each competency • Attempt to match issues from article with specific competency

4. COMPETENCY BASED OBJECTIVES • Medical Knowledge • knowledge about the established and evolving biomedical, clinical, and cognate (epidemiological and social-behavioral) sciences and their application to patient care

5. COMPETENCY BASED OBJECTIVES • Patient Care • family centered patient care developmentally and age appropriate compassionate and effective for treatment of health care problems and promotion of health

6. COMPETENCY BASED OBJECTIVES • Practice Based Learning • investigation and evaluation of patient care, and the assimilation of scientific evidence • Communication Skills • interpersonal and communication skills resulting in effective information exchange and learning with patients, families and professional associates

7. COMPETENCY BASED OBJECTIVES • System Based Practice • understanding systems of health care organization, financing, and delivery, and the relationship of one’s local practice and these larger systems • Professionalism • carrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populations

8. INTRODUCTION • Usual practice is to hospitalize young infants - especially those < 3 months of age with urinary tract infections due to • Risk of bacteremia and other SBI • Risk of renal scarring • “Ambulatory treatment of UTI in the 3m-5 year group has been shown to be safe, feasible and satisfactory to parents…” • No study of same topic to date in younger age group

9. HYPOTHESIS/AIM OF STUDY Specific challenges (e.g. IV access) and reluctance of ED physicians to discharge home young infants with bacterial infections during the first 24-48 hours of treatment could be addressed with successful OPD treatment with IV antibiotics in a “day treatment center” in infants 1-3 months of age

10. METHODS • Clinical protocol established in tertiary care Canadian hospital (Montreal) in 2005 • Eligible: all children 30-90 days of age with diagnosis of febrile UTI • LP? – at discretion of attending physician • If non toxic appearing with normal renal function, subjects received:

11. METHODS • Single dose of IV gentamicin (2.5 or 5mg/kg) given through IV catheter • Single dose of IV ampicillin • 2 or 3 doses of oral amoxicillin to be taken until 1st visit at DTC • Parents measured rectal temperature every 4 hours during IV home therapy • Exclusion criteria (these patients were hospitalized) • Age < 30 days • Toxic appearing or dehydrated • Abnormal renal function • “Dubious parental compliance” • H/O renal surgery • Abnormal CSF findings • Serious medical conditions

12. METHODS • DTC • Open 7 days/week • Staffed by hospitalists • Treatment continued • IV Gentamicin (5 mg/kg) Qday until “child was afebrile for ≥ 24 hours and urine culture results available” • Oral amoxicillin discontinued when gram negative bacilli identified; after gentamicin treatment stopped, oral amoxicillin was continued for 10 days • If 1st UTI  renal ultrasound and VCUG prior to DTC discharge

13. METHODS • “Retrospective cohort study” 1/1/2005-9/30/2007 • Infants 1-3 months of age with first UTI and history of fever in prior 48 hours or rectal temp ≥ 48 hours in the ED • Admission rosters were reviewed to find patients for the study: admitting or discharge diagnosis of UTI or pyelonephritis in 1-3 month olds

14. METHODS • “Retrospective cohort study” 1/1/2005-9/30/2007 • Definition of UTI • Suprapubic: any gm negative bacteria or > 10 X 106 colonies/L or • Catheterized: > 50 X 106 colonies/L of a single pathogen or 10 X 106 colonies/L of pseudomonas or • Treating physician decided diagnosis was UTI

15. STATISTICAL ANALYSIS • Multivariate and logistic regression used to determine if age was associated with “successful implementation of treatment protocol.” • “Appropriateness” of patient referral tot DTC or hospital was a major outcome variable • Covariates: age ≤ 60 days, distance home to hospital < 20km, ED physician experience ≤ 10 years, time of day

16. STATISTICAL ANALYSIS • “Successful treatment in the DTC” • Defined as: attendance at all visits, resolution of fever within 48 hours, negative control urine culture and blood culture results, and no hospitalization • Covariates: age ≤ 60 days, distance home to hospital < 20km, type of bacteria in urine culture (e coli v other bacteria)

17. RESULTS • See Figure 1 algorithm page 18 • 87% of infants (102/118) were referred to appropriate site • 2 sent to DTC that should have been hospitalized due to abnormal CSF • See Table 1, page 19 • Adherence to protocol lower for younger patients (p>.05)

18. RESULTS • Diagnosis of UTI made for 86.6% of patients sent to DTC (see Table 2) • Clinical course of UTI – see Table 3, page 20 • 7 patients were hospitalized from DTC • 5/6 children with bacteremia • 1 with GERD • Right hydronephrosis

19. RESULTS • Treatment considered “successful” for 86.2% of patients treated in DTC • 7/8 treatment failures defined as “failures” because they were admitted • Differences for success rates for younger v older groups (≤ 60 d v older) due to frequency of hospitalization for younger group

20. DISCUSSION • Ambulatory treatment of UTI for 30-90day old infants with febrile UTI’s with short term IV treatment is “feasible.” • “Treatment failures” (7/8) due to hospital admission; patients usually admitted due to positive blood cultures and were not clinically unstable • Need to complete VCUG and sonogram soon to rule out potential pathology • Prior studies looking at oral antibiotics for febrile UTI did not include younger population

21. DISCUSSION • Limitations • ?Generalizability of findings • Location • Population of participants • ?Long term followup • How was the definition of “success” created? • Attending physician had option to assign diagnosis of UTI without any laboratory evidence

22. DISCUSSION • Strengths of the study • Interesting question, important • Weaknesses of the study • Population very different (generalizability limited); impossible to perform in NYC • Author excluded parents who were “dubious”

23. COMPETENCY BASED OBJECTIVES • Medical Knowledge • knowledge about the established and evolving biomedical, clinical, and cognate (epidemiological and social-behavioral) sciences and their application to patient care • Treatment of febrile UTI in children

24. COMPETENCY BASED OBJECTIVES • Patient Care • family centered patient care developmentally and age appropriate compassionate and effective for treatment of health care problems and promotion of health • Parents may not understand issues surrounding UTI’s

25. COMPETENCY BASED OBJECTIVES • Practice Based Learning • investigation and evaluation of patient care, and the assimilation of scientific evidence • Scientific evaluation of hypothesis, methods, and conclusion of article • Communication Skills • interpersonal and communication skills resulting in effective information exchange and learning with patients, families and professional associates • Parental education and support critical

26. COMPETENCY BASED OBJECTIVES • System Based Practice • understanding systems of health care organization, financing, and delivery, and the relationship of one’s local practice and these larger systems • Who gets admitted and who will pay for this?Admission warranted on medical reasons? • Professionalism • carrying out professional responsibilities, adherence to ethical principles, and sensitivity to diverse patient populations • Patient education in diverse cultures