Leveraging real-world data from administrative claims and medical records to inform safety and effectiveness of piperacillin-tazobactam in the management of pediatric hospital-acquired pneumonia

被引：3

作者：

Blumenstock, Jesse A. ^{[1
]}

Faerber, Jennifer A. ^{[2
]}

Menon, Muida ^{[1
]}

Lawler, Rasheeda ^{[1
]}

Downes, Kevin J. ^{[1
]}

Kratz, Ellen ^{[1
]}

Erickson, Kelley ^{[4
]}

Haltzman-Cassenti, Brittany ^{[3
]}

Yildirim, Inci ^{[5
,6
]}

Hussaini, Laila ^{[7
]}

Elmontser, Mohnd ^{[8
]}

Sederdahl, Bethany K. ^{[9
]}

Hahn, Andrea ^{[10
,11
,12
]}

Thomson, Joanna ^{[13
,14
]}

Newland, Jason ^{[15
]}

Terrill, Cindy ^{[15
]}

Bradley, John ^{[16
,17
]}

Zachariah, Phillip ^{[18
]}

Younus, Muhammad ^{[19
]}

Mo, Jingping ^{[19
]}

Wible, Michele ^{[20
]}

Tawadrous, Margaret ^{[20
]}

Fisher, Brian T. ^{[1
,21
]}

机构：

[1] Childrens Hosp Philadelphia CHOP, Dept Pediat, Div Infect Dis, 3401 Civ Ctr Blvd, Philadelphia, PA 19104 USA

[2] Childrens Hosp Philadelphia, Dept Biomed & Hlth Informat, Philadelphia, PA USA

[3] MD Group, Patient Serv, Durham, NC USA

[4] Seattle Childrens, Canc & Blood Disorders Ctr Oncol, Seattle, WA USA

[5] Yale Inst Global Hlth, New Haven, CT USA

[6] Yale Sch Med, Dept Pediat, Infect Dis, New Haven, CT USA

[7] Emory Sch Med, Dept Pediat, Div Infect Dis, Atlanta, GA USA

[8] St Louis Univ, Dept Pathol, Div Anat & Clin Pathol, St Louis, MO USA

[9] Emory Univ, Dept Pediat, Atlanta, GA USA

[10] Childrens Natl Hosp, Div Infect Dis, Washington, DC USA

[11] Childrens Natl Res Inst, Ctr Genet Med Res, Washington, DC USA

[12] George Washington Univ, Dept Pediat, Sch Med & Hlth Sci, Washington, DC USA

[13] Cincinnati Childrens Hosp Med Ctr, Div Hosp Med, Cincinnati, OH USA

[14] Univ Cincinnati, Dept Pediat, Cincinnati, OH USA

[15] Washington Univ, Sch Med, Dept Pediat, St Louis, MO USA

[16] Univ Calif San Diego, Div Infect Dis, Dept Pediat, La Jolla, CA USA

[17] Rady Childrens Hosp San Diego, Div Infect Dis, San Diego, CA USA

[18] Columbia Univ, Irving Med Ctr, Dept Pediat, New York, NY USA

[19] Pfizer, Safety Surveillance Res, Collegeville, PA USA

[20] Pfizer, Global Prod Dev, Collegeville, PA USA

[21] Univ Penn, Perelman Sch Med, Ctr Clin Epidemiol & Biostat, Dept Biostat Epidemiol & Informat, Philadelphia, PA USA

来源：

AMERICAN JOURNAL OF EPIDEMIOLOGY | 2025年

关键词：

pediatric pharmacoepidemiology; real-world evidence; drug safety and effectiveness; infectious diseases; antibiotics; comparative safety and effectiveness; SENSITIVITY-ANALYSIS; CHILDREN;

D O I：

10.1093/aje/kwae251

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Pediatric-specific safety data are required during development of pharmaceutical agents. Retrospective studies can leverage real-world data to assess safety and effectiveness in children where prospective, controlled studies are not feasible. A retrospective cohort study combined data from Pediatric Health Information Systems (PHIS) and medical records to evaluate the safety and effectiveness of piperacillin/tazobactam (P/T) in pediatric patients with hospital-acquired pneumonia (HAP). After identifying 407 patients diagnosed with HAP receiving P/T (n = 140) or comparator (n = 267) HAP-appropriate antibiotics between 2003-2016 across 7 pediatric institutions, we evaluated comparative risk of a serious adverse event (SAE). Clinical improvement 14 days after therapy initiation was studied as a secondary outcome. Incidence rate ratios (IRRs) were calculated to compare between exposure groups using inverse probability-weighted Poisson regression models. The unadjusted and adjusted IRRs with 95% CIs for SAEs were 1.26 (0.66-2.39) and 1.24 (0.65-2.35). The unadjusted and adjusted ORs with 95% CIs for clinical improvement were 1.14 (0.56-2.34) and 1.50 (0.67-3.38). Point estimates from this retrospective analysis suggest similar safety and clinical effectiveness of P/T and comparator antibiotics for treating HAP. However, due to wide CIs, actual between-group differences cannot be excluded. Existing real-world data can be utilized to inform pediatric-specific safety and effectiveness of medications used in off-label settings.This article is part of a Special Collection on Pharmacoepidemiology.

引用

页数：10