Trial Outcomes & Findings for Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit (NCT NCT03440918)
NCT ID: NCT03440918
Last Updated: 2020-04-22
Results Overview
Days of antibiotic therapy a participant receives following randomization will be measured
COMPLETED
NA
271 participants
14 days
2020-04-22
Participant Flow
528 patients in the pediatric ICU were on antibiotics \< 1 calandar day and were assessed for eligibility during the study period, February 15, 2018 to April 11, 2019. 257 were excluded and did not undergo randomization.
No patients enrolled in the study were excluded before assignment to groups.
Participant milestones
| Measure |
Usual Care Antimicrobial Stewardship
Participants received usual care audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
In addition to usual care audit and feedback of antimicrobial orders, the stewardship team additionally recommended procalcitonin (PCT) testing and treatment per algorithm. PCT was used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
138
|
|
Overall Study
COMPLETED
|
133
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
16
|
Reasons for withdrawal
| Measure |
Usual Care Antimicrobial Stewardship
Participants received usual care audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
In addition to usual care audit and feedback of antimicrobial orders, the stewardship team additionally recommended procalcitonin (PCT) testing and treatment per algorithm. PCT was used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
16
|
Baseline Characteristics
Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Usual Care
n=133 Participants
Usual Care audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to usual care audit and feedback of antimicrobial orders, the stewardship team additionally recommended procalcitonin (PCT) testing and treatment per algorithm. PCT was be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
126 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
2.3 years
n=5 Participants
|
1.6 years
n=7 Participants
|
1.89 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=5 Participants
|
137 participants
n=7 Participants
|
270 participants
n=5 Participants
|
|
Location at Enrollment
Medical / Surgical ICU
|
111 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Location at Enrollment
Cardiac ICU
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Vasopressor Support
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Mechanical Ventilation
|
61 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Fever at enrollment
|
79 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Recent surgery
|
37 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Antibiotic Indication
Sepsis
|
51 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Antibiotic Indication
Pneumonia
|
59 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Antibiotic Indication
Other
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Final Diagnosis
Pneumonia
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Final Diagnosis
Aspiration pneumonia
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Final Diagnosis
Tracheitis
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Final Diagnosis
Viral illness
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Final Diagnosis
Non-infectious etiology
|
23 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Final Diagnosis
Other
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Intention to treat
Days of antibiotic therapy a participant receives following randomization will be measured
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Days of Antibiotic Therapy in the First 14 Days Following Randomization
|
7.6 days
Interval 3.0 to 11.8
|
6.6 days
Interval 3.1 to 10.9
|
SECONDARY outcome
Timeframe: up to14 daysPopulation: intention to treat
Defined as vancomycin, daptomycin, amikacin, ceftazidime, cefepime, piperacillin/tazobactam, aztreonam, carbapenems
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Duration of Broad-spectrum Antibiotic Therapy
|
0 days
Interval 0.0 to 1.8
|
0.086 days
Interval 0.0 to 2.6
|
SECONDARY outcome
Timeframe: up to 14 daysPopulation: intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)
Number of patients with an appropriate antibiotic escalation or de-escalation based on patient's clinical status and available supporting laboratory evidence, or lack thereof, of specific type of infection
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Number of Patients With an Antibiotic Change
|
111 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysPopulation: intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)
All-cause mortality
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
30-day Mortality
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysPopulation: intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)
Re-initiation of any antibiotic for a proven or suspected bacterial infection
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Re-initiation of Antibiotics for a Bacterial Infection
|
NA Participants
Insufficient number of participants with events
|
NA Participants
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: up to 14 daysPopulation: intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)
Hospital days spent in the intensive care unit
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Length of Intensive Care Unit Stay
|
2 days
Interval 1.0 to 5.0
|
2 days
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Until hospital discharge, an average of 7 daysPopulation: intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)
Hospital days admitted to the hospital
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Length of Overall Hospital Stay
|
7 days
Interval 3.0 to 12.0
|
6 days
Interval 4.0 to 14.0
|
SECONDARY outcome
Timeframe: up to 14 daysPopulation: intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)
Days spent using invasive ventilation methods (not including supplementary oxygen via nasal cannula or Vapotherm support)
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Ventilator Days
|
3.9 days
Interval 2.4 to 6.1
|
4.4 days
Interval 2.5 to 11.1
|
SECONDARY outcome
Timeframe: up to 14 daysPopulation: intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)
Antibiotic-associated complications including rash, neutropenia, thrombocytopenia, acute kidney injury \[defined as increase in serum creatinine \> 0.3 mg per dL or \> 1.5-fold from baseline, or urine output \< 0.5 mL per kg per hour for more than six hours\], hepatotoxicity \[defined as \> 2-fold increase in alanine aminotransferase, ALT, or conjugated bilirubin\], or C. difficile infection will be recorded
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Number of Participants With Antibiotic-associated Complications
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysPopulation: intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)
Identification/growth of a multi-drug resistant organism from a sterile culture site. Multi-drug resistant organisms will be defined as methicillin-resistant S. aureus, vancomycin-resistant Enterococcus, 3rd generation cephalosporin non-susceptible Enterobacteriaceae, multi-drug resistant Pseudomonas aeruginosa \[resistant to aminoglycosides, cephalosporins, floroquinolones and carbepenems\], carbepenem-resistant Acinetobacter, and Candida spp obtained from otherwise sterile sites \[i.e. blood or urine cultures\]
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Infection With a Multi-drug Resistant Organism
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 14 daysPopulation: intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)
Cost of antibiotic course will be obtained from hospital billing data
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Antibiotic Cost
|
NA dollars
data not collected
|
NA dollars
data not collected
|
SECONDARY outcome
Timeframe: up to 5 daysPopulation: intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)
Rate of clinical provider compliance with adherence to suggested antibiotic escalation or de-escalation made by the antimicrobial stewardship team based on procalcitonin levels will be tracked
Outcome measures
| Measure |
Baseline Antimicrobial Stewardship
n=133 Participants
Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
|
Procalcitonin-Guided Antimicrobial Stewardship
n=137 Participants
In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
|
|---|---|---|
|
Number of Participants Whose Provider Adhered to the Procalcitonin-guided Algorithm
|
123 Participants
|
121 Participants
|
Adverse Events
Baseline Antimicrobial Stewardship
Procalcitonin-Guided Antimicrobial Stewardship
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place