Trial Outcomes & Findings for PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT (NCT NCT04158804)

NCT ID: NCT04158804

Last Updated: 2025-03-20

Results Overview

Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 700 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-03-20

Participant Flow

Participant milestones

Measure	Standard of Care (SOC) PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
Overall Study STARTED	357	343
Overall Study COMPLETED	357	343
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT

Baseline characteristics by cohort

Measure	Standard of Care (SOC) n=357 Participants PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 Participants PCT results were posted in the medical record and ASP emailed recommendation to the medical team.	Total n=700 Participants Total of all reporting groups
Age, Continuous	73 years n=5 Participants	71 years n=7 Participants	72 years n=5 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	164 Participants n=7 Participants	330 Participants n=5 Participants
Sex: Female, Male Male	191 Participants n=5 Participants	179 Participants n=7 Participants	370 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants	29 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	305 Participants n=5 Participants	303 Participants n=7 Participants	608 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Pneumonia Type CAP (community-acquired pneumonia)	205 Participants n=5 Participants	196 Participants n=7 Participants	401 Participants n=5 Participants
Pneumonia Type HCAP (healthcare-associated pneumonia)	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Pneumonia Type Aspiration	89 Participants n=5 Participants	82 Participants n=7 Participants	171 Participants n=5 Participants
Pneumonia Type Other	53 Participants n=5 Participants	50 Participants n=7 Participants	103 Participants n=5 Participants
Pneumonia Severity Index (PSI) Class I (lowest severity)	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Pneumonia Severity Index (PSI) Class II	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Pneumonia Severity Index (PSI) Class III	78 Participants n=5 Participants	64 Participants n=7 Participants	142 Participants n=5 Participants
Pneumonia Severity Index (PSI) Class IV	144 Participants n=5 Participants	156 Participants n=7 Participants	300 Participants n=5 Participants
Pneumonia Severity Index (PSI) Class V (highest severity)	76 Participants n=5 Participants	63 Participants n=7 Participants	139 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")

Outcome measures

Measure	Standard of Care (SOC) n=357 Participants PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 Participants PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
Short Treatment of Pneumonia	47 Participants	87 Participants

SECONDARY outcome

Timeframe: 30 days

Composite endpoints include: all-cause in-hospital mortality, all-cause mortality after discharge (as available), hospital readmission, septic shock (vasopressor use for > 1 hour), mechanical ventilation (via endotracheal tube), required dialysis, lung abscess/empyema/cavitation/necrotizing pneumonia

Outcome measures

Measure	Standard of Care (SOC) n=357 Participants PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 Participants PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
Composite Safety Adverse Event Rate	72 Participants	90 Participants

SECONDARY outcome

Timeframe: 30 days

Duration of antibiotics prescribed at discharge

Outcome measures

Measure	Standard of Care (SOC) n=357 Participants PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 Participants PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
Antibiotic Exposure at Discharge	0 days Interval 0.0 to 4.0	0 days Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 30 days

Days of therapy per 1000 patient days (inclusive of antibiotics prescribed at discharge)

Outcome measures

Measure	Standard of Care (SOC) n=357 Participants PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 Participants PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
Days of Therapy Per 1000 Patient Days	1.25 Days of Therapy Per 1000 Patient Days Interval 0.78 to 2.67	1.14 Days of Therapy Per 1000 Patient Days Interval 0.67 to 2.0

SECONDARY outcome

Timeframe: 30 days

Length of stay in hospital

Outcome measures

Measure	Standard of Care (SOC) n=357 Participants PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 Participants PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
Length of Stay	4 days Interval 2.0 to 7.0	4 days Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 30 days

Number of Participants Admitted to the ICU

Outcome measures

Measure	Standard of Care (SOC) n=357 Participants PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 Participants PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
ICU Admissions	43 Participants	49 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Treatment or readmission for CDI until day 30 after enrollment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Costs associated with primary hospitalization, readmission for CDI, and loss of function

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care (SOC)

Serious events: 76 serious events

Other events: 0 other events

Deaths: 19 deaths

PCT/ASP

Serious events: 81 serious events

Other events: 0 other events

Deaths: 17 deaths

Serious adverse events

Measure	Standard of Care (SOC) n=357 participants at risk PCT results were hidden from the medical record and no ASP recommendation given.	PCT/ASP n=343 participants at risk PCT results were posted in the medical record and ASP emailed recommendation to the medical team.
General disorders Death	5.3% 19/357 • Number of events 19 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.	5.0% 17/343 • Number of events 17 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.
Infections and infestations Septic Shock	3.1% 11/357 • Number of events 11 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.	3.8% 13/343 • Number of events 13 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.
Respiratory, thoracic and mediastinal disorders Mechanical Ventilation	1.4% 5/357 • Number of events 5 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.	3.8% 13/343 • Number of events 13 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.
Renal and urinary disorders Dialysis	0.84% 3/357 • Number of events 3 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.	0.00% 0/343 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.
Infections and infestations Empyema	0.84% 3/357 • Number of events 3 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.	1.7% 6/343 • Number of events 6 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.
General disorders Readmission	13.2% 47/357 • Number of events 47 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.	16.6% 57/343 • Number of events 57 • Adverse event data was collected starting at enrollment day until 30 days after enrollment.

Other adverse events

Adverse event data not reported

Additional Information

Michael K. Mansour, MD, Ph.D.

Massachusetts General Hospital

Phone: 617-726-6726

Email: mkmansour@mgb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place