ORIGINAL ARTICLE

Outcomes of Single-Dose Empirical Antibiotic

Treatment in Children With Suspected Sepsis Implemented
in the Emergency Department
Suwimon Khanthathasiri, MD,* Worapant Kriengsoontornkij, MD,* Apichaya Monsomboon, MD,†
Wanatpreeya Phongsamart, MD,* Keswadee Lapphra, MD,* Orasri Wittawatmongkol, MD,*
Supattra Rungmaitree, MD,* and Kulkanya Chokephaibulkit, MD*‡

Objectives: Implementing a single-dose empirical antibiotic (SDEA) strat-

egy at the emergency department (ED) in children with suspected sepsis may
S epsis is a leading cause of death globally with more than
8 million people dying of sepsis annually.1–3 In 2000–2015,
it was reported that one-third of deaths in children were from in-
improve outcomes. We aim to evaluate the outcomes of the SDEA strategy for fection, and the 3 most common causes of death were pneumonia,
children with suspected sepsis at the ED in a tertiary care center in Bangkok. diarrhea, and malaria.1
Methods: Children who met the predefined checklist screening criteria There are many factors affecting the clinical outcome of sep-
for suspected sepsis were administered single-dose intravenous cefotaxime sis. A major factor is the time to initiating effective antibiotics.
100 mg/kg, or meropenem 40 mg/kg if they were immunocompromised or Multiple studies in adults have shown that delayed antibiotic ther-
recently hospitalized. The medical records of children diagnosed with sep- apy for sepsis results in prolongation of hospitalization, increased
sis and septic shock caused by bacterial or organ-associated bacterial infec- duration and severity of end organ dysfunction, morbidity, and
tions before and after implementation of the SDEA strategy were reviewed. mortality.4–6 Delayed antibiotic therapy in septic shock leads to
Results: A total of 126 children with sepsis before and 127 after imple- a significant increase in the risk of mortality, whereas the impact
mentation of the SDEA strategy were included in the analysis. The time on sepsis without shock was less so.4 Delayed antibiotic therapy
from hospital arrival to antibiotic initiation was significantly reduced after in adults increased the risk of mortality by 7.6% each hour after
implementation of the SDEA strategy: median, 241 (110–363) minutes be- diagnosis of sepsis.5 Likewise, in children with sepsis, delaying an-
fore versus 89 (62–132) minutes after (P < 0.001), with an increased num- tibiotic treatment for more than 3 hours increased morbidity and
ber of patients starting antibiotics within 3 hours of hospital arrival: 42.1% mortality by 3.9-fold and extended the duration of end-organ dam-
vs 85.0% (P < 0.001). Comparing before and after SDEA implementation, age.7 Recently, a systematic review found no difference in mortality
children receiving SDEA had a shorter median duration of antibiotic therapy: if antibiotic administration was started within 1 hour or less than
7 (5–13.3) versus 5 (3–7) days (P = 0.001), shorter length of hospital stay: 10 3 hours.8
(6–16.3) versus 7 (4–11) days (P = 0.001), and fewer intensive care unit ad- The emergency department (ED) at most tertiary care centers
missions: 30 (23.8%) versus 17 (13.4%; P = 0.036); however, mortality was are generally busy, and this can lead to a slow admission process
not different: 3 (2.4%) in both groups. In multivariate analysis, SDEA strat- and delayed initiation of antibiotic treatment, with the first admin-
egy was the independent factor associated with reduced intensive care unit istration often occurring after arriving at the pediatric ward. We
admission or death. Adherence to SDEA was 91.4%. Single-dose empirical implement a single-dose empirical antibiotic (SDEA) strategy at
antibiotic was retrospectively considered not necessary for 22 children the ED for children with suspected sepsis to prevent delayed initi-
(11.9%), mostly diagnosed with viral infections afterward. ation of antibiotic treatment. This study reports the impact of our
Conclusions: Single-dose empirical antibiotic at the ED is an effective SDEA strategy on the outcomes of sepsis in children.
strategy to reduce the time from hospital arrival to antibiotic initiation
and can help improve outcomes of sepsis in children.
Key Words: empirical antibiotics, sepsis outcome, Thailand
METHODS
(Pediatr Emer Care 2022;00: 00–00)
Study Design and Data Collection
This study was conducted at Siriraj hospital, a large public
tertiary care and referral center in Bangkok. The SDEA strategy
was developed by a multidisciplinary group and was implemented
From the Departments of *Pediatrics and †Emergency Medicine and ‡Siririaj at the ED in May 2018. If a child at the triage station met the
Institute of Clinical Research, Faculty of Medicine Siriraj Hospital, Mahidol criteria of suspected sepsis, they were assessed by an ED clinician
University, Bangkok, Thailand. within 15 minutes to approve the SDEA, targeting administration
Disclosure: The authors declare no conflict of interest.
Reprints: Kulkanya Chokephaibulkit, MD, Department of Pediatrics, Faculty of
within 1 hour of hospital arrival (and after a blood drawn for bac-
Medicine Siriraj hospital, 2 Wanglang Rd, Bangkoknoi, Bangkok 10700, terial culture). The criteria of suspected sepsis included children
Thailand (e‐mail: Kulkanya.cho@mahidol.ac.th). who had fever and abnormal vital signs for age that met the sys-
Supplemental digital content is available for this article. Direct URL citations temic inflammatory response syndrome criteria, infants who had
appear in the printed text and are provided in the HTML and PDF versions
of this article on the journal’s Web site (www.pec-online.com).
high fever and looked toxic or with convulsion, and immunocom-
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. promised children who had fever or a history of fever.9 Single-dose
This is an open-access article distributed under the terms of the Creative intravenous cefotaxime 100 mg/kg was administered, or meropenem
Commons Attribution-Non Commercial-No Derivatives License 4.0 40 mg/kg if the child was immunocompromised or recently hospital-
(CCBY-NC-ND), where it is permissible to download and share the work
provided it is properly cited. The work cannot be changed in any way or
ized.10 A single normal saline solution (NSS) bolus dose was admin-
used commercially without permission from the journal. istered in children with unstable hemodynamics. Exclusion criteria
ISSN: 0749-5161 for SDEA treatment included viral infection–associated symptoms

Pediatric Emergency Care • Volume 00, Number 00, Month 2022 www.pec-online.com 1
Khanthathasiri et al Pediatric Emergency Care • Volume 00, Number 00, Month 2022

in children, such as maculopapular rash, or other viral diagnosis RESULTS

(Supplemental Fig. 1, http://links.lww.com/PEC/A996).
We retrospectively reviewed the medical records of inpatient Study Population
children younger than 15 years who were diagnosed with sepsis,
A total of 635 children visited the ED, and 244 received SDEA
septic shock caused by bacterial or organ-associated bacterial infec-
during the study period. Among the children who received SDEA,
tions by International Classification of Diseases, Tenth Revision,
185 (75.8%) were hospitalized, 38 (15.6%) were discharged home
collectively defined as sepsis, and visited the ED before (January
with follow-up after pediatric consultation, and 21 (8.6%) were re-
2017 to December 2017) and after the SDEA strategy implementa-
ferred to other hospitals because of health care coverage. Of those
tion (May 2018 to December 2019). The period between January
who were discharged home, 15 (39.5%) received oral antibiotics,
2018 and April 2018 was not included as this time was used to de-
none revisited ED or had worsening of clinical symptoms, and all
velop the SDEA work instruction and train the ED staff. The demo-
recovered. All children referred were hospitalized, but none were
graphic data, the time from hospital arrival to antibiotic initiation,
admitted to the ICU or died. There were 51 patients (40.1%) also
and outcomes of sepsis were collected. This study was approved
received a bolus dose of NSS at the ER. Thirteen children (2.0%)
by the institutional ethics committee at Siriraj Hospital.
who met the predefined criteria but did not receive SDEA, all due
to the clinician's judgment of probable viral infection, recovered
well and did not receive antibiotic after admission. There were no
Data Analysis adverse reactions reported following SDEA.
For children hospitalized at Siriraj Hospital, parenteral antibiotic
Descriptive analyses were presented using median (interquartile treatment was not continued in 22 children (11.9%) because of other
range [IQR]) and range. Variables for patients with predefined Inter- noninfectious diagnoses, whereas for the 163 children (88.1%) for
national Classification of Diseases, Tenth Revision for sepsis before whom antibiotic treatment was continued, 36 (22.1%) had a final
and after the SDEA strategy implementation at the ED were compared diagnoses at discharge of viral infection (Fig. 1).
using Mann-Whitney U test for continuous outcomes, and χ2 or by
Fisher exact test for categorical outcomes. We evaluated the factors as-
sociated with admission to intensive care unit (ICU) or death in univar- Impact of SDEA Strategy
iate analysis including being in the before or after SDEA strategy pe- There were 126 children before and 127 children after the
riod, age, host immune factors, receiving antibiotic at the ED or at SDEA strategy was implemented who visited the ED and were
the ward, and time from hospital arrival to antibiotic initiation. All of hospitalized with a final diagnosis of sepsis and septic shock
these factors were put into the multivariate analysis using logistic re- caused by bacterial or organ-associated bacterial infections. The
gression analysis. All statistical analyses were performed using SPSS demographic characteristics of these 2 groups of children are
Statistics for Windows, version 20.0 (IBM Corp, Armonk, NY). shown in Table 1. The single-dose antibiotic prescribed at the ER

FIGURE 1. Consort diagram of the study population.

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Pediatric Emergency Care • Volume 00, Number 00, Month 2022 Single-dose Antibiotic at ED for Children

TABLE 1. Baseline Characteristics of Pediatric Patients Diagnosed With Sepsis and Septic Shock Caused by Bacterial or
Organ-Associated Bacterial Infections: Comparing Before and After the SDEA Strategy (n = 253)

Before SDEA Strategy After SDEA Strategy

Characteristic Group (n = 126) Group (n = 127) P
Age, median age (IQR), mo 20.5 (4–35) 24.0 (11–60) 0.008
Range of age, n (%)
<3 mo 30 (23.8) 12 (9.4) 0.002
<1 y 50 (39.7) 33 (26.0) 0.023
≥1 y 76 (60.3) 94 (74.0) 0.021
Sex, n (%)
Male 67 (53.2) 72 (56.7) 0.614
Female 59 (46.8) 55 (43.3) 0.573
Comorbid conditions, n (%) 92 (73.0) 77 (60.6) 0.045
Congenital anomalies 17 (13.5) 5 (3.9) 0.007
Neuromuscular disease 18 (14.3) 9 (7.1) 0.070
Cardiovascular disease 13 (10.3) 4 (3.1) 0.025
Chronic lung disease 9 (7.1) 3 (2.4) 0.084
Chronic liver disease 8 (6.3) 6 (4.7) 0.596
CAKUT 10 (7.9) 5 (3.9) 0.195
Hematologic diseases 2 (1.6) 3 (2.4) 1.000
Malignancy with chemotherapy 30 (23.8) 46 (36.2) 0.039
Primary immune deficiency 13 (10.3) 7 (5.5) 0.170
Host immune status, n (%)
Immunocompetent 78 (61.9) 67 (52.8) 0.163
Immunocompromised 48 (38.1) 60 (47.2) 0.144
Immunocompromised with neutropenia 29 (23.0) 48 (37.8) 0.011
Vital signs met the systemic inflammatory response syndrome criteria by age
Body temperature, mean (SD), °C 38.4 (1.0) 38.9 (1.07) 0.003
Tachypnea or apnea, n (%) 47 (37.3) 60 (47.2) 0.127
Tachycardia or bradycardia, n (%) 109 (86.5) 119 (93.7) 0.061
Hypotension or poor perfusion, n (%) 14 (11.1) 11 (8.7) 0.535
Sites of infections identified*
CNS infection 11 1 0.003
Bacteremia 22 13 0.104
Respiratory infection 38 31 0.306
Gastrointestinal infection 26 19 0.254
Urinary tract infection 16 15 0.702
Other organ-specific infection† 14 23 0.113
No organ-specific infection 30 44 0.059
Time from hospital arrival to administration of the first dose of antibiotics, n (%)
1h 9 (7.1) 29 (22.8) <0.001
1–2 h 25 (19.8) 57 (44.9) <0.001
>2–3 h 19 (15.1) 22 (17.3) 0.636
>3 h 73 (57.9) 19 (15.0) <0.001
Outcomes of hospitalization
Median time to first-dose antibiotic administration, minutes (IQR) [range] 241 (110, 363) [24, 1058] 89 (62, 132) [14, 1154] <0.001
No. patients initiated ATB within 3 h of hospital arrival, n (%) 53 (42.1) 108 (85.0) <0.001
Median duration of antibiotic therapy (IQR) [min, max], d 7 (5.0, 13.3) [1, 177] 5 (3, 7) [0, 21] <0.001
Median length of hospitalization (IQR) [min, max], d 10 (6.0–16.3) [1, 177] 7 (4, 11) [0, 60] <0.001
No. patients who required ICU admission, n (%) 30 (23.8) 17 (13.4) 0.036
Median ICU length of stay (IQR) [min, max], d 5.5 (3, 9) [1, 17] 3 (2, 8) [1, 40] 0.163
No. patients who required mechanical ventilation, n (%) 16 (12.6) 8 (6.3) 0.090
Median duration of mechanical ventilation (IQR) [min, max], d 7.5 (4–11) [1, 17] 9 (2, 21.75) [2, 35] 0.653
No. patients who required inotropic therapy, n (%) 17 (13.5) 7 (5.5) 0.033
Median duration of inotropic therapy (IQR) [min, max], d 2 (1–3) [1, 7] 1 (1, 4) [1, 6] 0.852
No. patients with organ dysfunction, n (%) 19 (15.1) 9 (7.1) 0.047
Mortality, n (%) 3 (2.4) 3 (2.4) 1.000
Total number of conditions was more than the number of patients because 1 patient may have multiple conditions.
*A patient may have multiple sites of infections.
†
Other organ-specific infections were upper respiratory tract infection (21 patients), skin and soft tissue infection (11 patients), and hepatobiliary system
infection (5 patients).
CAKUT indicates congenital anomalies of the kidney and urinary tract; CNS, central nervous system.

© 2022 The Author(s). Published by Wolters Kluwer Health, Inc. www.pec-online.com 3

Khanthathasiri et al Pediatric Emergency Care • Volume 00, Number 00, Month 2022

was cefotaxime in 64 children (50.3%), meropenem in 62 children death (adjusted odds ratio, 0.384 [95% confidential interval
(48.8%), and piperacillin-tazobactam in 1 child. Those in the 0.180–0.822]; P = 0.014), after adjusting for the lapsed time from
after-SDEA strategy group were older (median age, 24.0 vs hospital arrival to antibiotic initiation (Table 2).
20.5 months; P = 0.008) and had less comorbidities (60.6% vs
73.0%, P = 0.045) and a higher proportion of neutropenic patients
(37.8% vs 23.0%, P = 0.011) compared with the before-SDEA DISCUSSION
group, but there was no difference in overall immunocompro- Early initiation of appropriate antibiotic therapy for sepsis
mised conditions between groups (47.2% vs 38.1%, P = 0.144). unambiguously results in improved outcomes. The Surviving Sep-
The before- SDEA strategy group also had more central nervous sis Campaign 2020 recommends starting antibiotic therapy within
system infections. Overall, 37 bacterial pathogens (29.1%) were 1 hour of recognition of septic shock and within 3 hours in
identified in patients from both periods, with Salmonella (n = 10 sepsis-associated organ dysfunction.11 Ensuing that all patients
[27%]), Escherichia coli (n = 6 [16.2%]), and methicillin-sensitive initiate appropriate antibiotic therapy within this period in the ER of
Staphylococcus aureus (n = 5 [13.5%]) as the most common patho- a tertiary referral hospital is a challenge. In our setting in Thailand,
gens. In vitro susceptibility tests reported resistance to the SDEA in 8 inadvertent morbidity and mortality are rooted from delayed pediat-
cases, including 4 of 10 Salmonella isolates. All of these children had ric consultation, a slow admission process, and an inefficient
their treatment switched to appropriate antibiotics with no worsening pharmacy-dispensing process. To overcome these challenges, we
of clinical symptoms before switching. developed a work instruction for physicians in the ED to expedite
The median time from hospital arrival to first administration the clinical evaluation and initiation of single-dose antibiotic empir-
of antibiotics was 89 minutes for children in the after-SDEA strat- ical treatment for children with suspected sepsis that does not re-
egy group, significantly shorter than the 241 minutes for children quire pediatric consultation.
in the before-SDEA strategy group. The number of patients who Following several multidisciplinary meetings over 4 months,
received their first antibiotic treatment within 3 hours increased an SDEA strategy work instruction was finalized and implemented
from 42.1% before implementation of the SDEA strategy to in the ED. The checklist criteria were not too broad but sufficient to
85.0% after (Table 1). In all patients of both groups, we found that cover all severe cases of pediatric sepsis. The streamline process
initiating antibiotic within 3 hours of hospital arrival reduced the to- was implemented with the target time from hospital arrival to
tal duration of antibiotic treatment (5 vs 7 days, P = 0.001), and SDEA administration of 1 hour. This report showed that this SDEA
length of stay (7 vs 10 days, P < 0.001), but did not affect the length strategy is feasible and safe, and adherence to the work instruction
of ICU admission or death (Supplementary Table 1, http://links. was very high (91.4%). Only 23% of the children achieved the tar-
lww.com/PEC/A997). get of receiving SDEA within 1 hour; however, 85% received their
Compared with before the implementation, the outcomes of first dose of antibiotic within 3 hours.
hospitalization in the after-SDEA strategy group were better: shorter To ease the management, our SDEA strategy used 2 choices
median duration of antibiotic therapy (7 vs 5 days, P < 0.001), shorter of antibiotics in standing order: cefotaxime for general cases and
length of hospitalization (10 vs 7 days, P < 0.001), lower proportions meropenem for patients who were immunocompromised or
of ICU admissions (23.8% vs 13.4%, P = 0.036), lower proportions suspected of having hospital-associated infections. The choice of
requiring inotropic therapy (13.5% vs 5.5%, P = 0.033), and fewer empirical antibiotic will depend on the local drug susceptibilities
with organ dysfunction (15.1% vs 7.1%, P = 0.047). Of note, the and may be different in children compared with adults where re-
mortality rates were low, with no difference between before and after sistant pathogens are found more often. We found that our SDEA
SDEA. In multivariate analysis, being in the after-SDEA strategy regimens were effective in most children with identifiable patho-
period was the only factor associated with lower ICU admission or gens. Of note, Salmonella, E. coli, and methicillin-sensitive S.

TABLE 2. Multivariate Analysis of Factors Associated With ICU Admission or Death in Pediatric Patients Diagnosed With Sepsis and
Septic Shock Cause by Bacterial or Organ-Associated Bacterial Infections (n = 253)

Mortality and ICU Admission

Crude Odds Adjust Odds
Factors Yes (n = 50) No (n = 203) (95% CI) P (95% CI) P
Before SDEA strategy group 32 (64.0) 94 (46.3) 1 0.027 1 0.014
After SDEA strategy group 18 (36.0) 109 (53.7) 0.485 (0.256, 0.920) 0.384 (0.180, 0.822)
Age 37 (74.0) 121 (59.6) 1 0.063 1 0.058
≥1 y
<1 y 13 (26.0) 82 (40.4) 0.518 (0.260, 1.035) 0.494 (0.238, 1.026)
Host
Immunocompetent host 27 (54.0) 118 (58.1) 1 0.597 1 0.442
Immunocompromised host 23 (46.0) 85 (41.9) 1.183 (0.635, 2.203) 0.743 (0.349, 1.584)
Without any comorbidity 11 (22.0) 79 (38.9) 1 0.028 1 0.061
Immunocompromised or with 39 (78.0) 124 (61.1) 2.259 (1.093, 4.669) 2.273 (0.963, 5.367)
congenital/anatomical defect
Received first-dose antibiotic at the ER 35 (70.0) 139 (68.5) 1 0.835 1 0.120
Received first-dose antibiotic at ward 15 (30.0) 64 (31.5) 0.931 (0.475, 1.825) 0.387 (0.117, 1.280)
Time from hospital arrival to antibiotic initiation
≤3 h 31 (62.0) 130 (64.0) 1 0.788 1 0.391
>3 h 19 (38.0) 73 (36.0) 0.931 (0.475, 1.825) 1.615 (0.540, 4.829)

4 www.pec-online.com © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Pediatric Emergency Care • Volume 00, Number 00, Month 2022 Single-dose Antibiotic at ED for Children

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