Pneumonia, BacterialProSAVENCT04158804
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
A study testing procalcitonin in people with Pneumonia, Bacterial, run by Massachusetts General Hospital at 6 sites in United States.
Trial summary
Trials comparing PCT-guided antibiotic algorithms to standard management show a significant reduction in antibiotic exposure without an increase in mortality or treatment failure. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- procalcitonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 May 2020to 17 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized adult patients ≥ 18 years of age
- Suspected or confirmed pneumonia <28 days at time of admission to the hospital (ED) who are prescribed antibiotics
- Minimum of 2 (two) blood samples available for PCT value assessment within 24 hours of hospitalization
Who cannot join
- Patient has tested positive for SARS-CoV-2
- Non-hospitalized patients
- Patients admitted to home health
- Major surgeries, defined as any procedure in which an incision is made with the exception of superficial procedures (eyes, cornea, skin, dental procedures), organs removed, or normal anatomy altered (e.g. open thoracic, abdominal and/or major orthopedic surgery), in the past 1 month or expected surgical procedure or patient receiving antibiotics for surgical prophylaxis
- Active metastatic cancer or neuroendocrine tumor or liquid tumor and/or on check point inhibitors within 3 months or has signs of mucositis (e.g. mouth lesions or intestinal bleeding)
- Known pregnancy
Show all 27Show fewer
- Primary and acquired cell-mediated immune deficiency (HIV with CD4 <350 cells/mm³; receipt of systemic chemotherapy and/or biologics in the past 3 months for reasons other than malignancy)
- Infection where long course antibiotics are the standard of care(>2 weeks) other than anti-inflammatory reasons.
- Neutropenia (<1,500 ANC)
- Concomitant non-pulmonary bacterial infection that requires antibiotic therapy based on an active medical team decision
- Antibiotics given for non-infectious indications (e.g. rifaximin for hepatic encephalopathy)
- Patients with cystic fibrosis
- Patients receiving dialysis
- Patients with solid organ transplant, bone marrow transplant or stem cell transplant recipient
- ST elevation myocardial infarction
- Prior enrollment into this study within 30 days
- Patient experiencing major trauma defined as any injury that could cause prolonged disability and/or an Injury Severity Score >15, and/or burns or patient under extracorporeal circulation confirmed by a second research staff member.
- Patient with acute viral hepatitis and/or decompensated severe liver cirrhosis (Child-Pugh Class C).
- Patient with prolonged or severe cardiogenic shock, defined as decreased cardiac output leading to end organ injury (e.g. severe hypotension or AKI or oliguria or altered mental status or cool extremities or respiratory distress AND evidence of metabolic acidosis on lab testing)
- Patient with pancreatitis, chemical pneumonitis or heat stroke
- Active infection with invasive fungal pathogen (e.g. candidiasis, aspergillosis) or plasmodium falciparum malaria or mycobacteria
- Patient under treatment with OKT3 antibodies, OK-432, interleukins, TNF-alpha and other drugs stimulating the release of pro-inflammatory cytokines or resulting in anaphylaxis.
- Patient is under hospice care
- Patient with ventilator associated pneumonia
- Patients with untreated, active, and symptomatic autoimmune disease
- Patients with empyema, abscess, or cavitary/necrotizing pneumonia
- Patients actively enrolled in other clinical trial involving immunomodulatory therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Massachusetts General Hospital
Boston, Massachusetts, 02114
Texas Health Harris Methodist Hospital
Fort Worth, Texas, 76104
Martha's Vineyard Hospital
Oak Bluffs, Massachusetts, 02557
North Shore Medical Center
Salem, Massachusetts, 01970
Charlotte Hungerford Hospital
Torrington, Connecticut, 06790
About this study
Official title: PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs
Trials comparing PCT-guided antibiotic algorithms to standard management show a significant reduction in antibiotic exposure without an increase in mortality or treatment failure. Despite this strong evidence from multiple studies a recent prospective multicentric interventional trial in the US fell short of demonstrating antibiotic reductions by PCT-guided antibiotic management. Amongst other limitations the authors of that study concluded that successful implementation of PCT may require closer educational oversight. As such, this study will compare effectiveness and safety of antibiotic prescription guided by a PCT-algorithm via a Stewardship Team over standard guidelines in hospitalized adult patients with suspected or confirmed LRTI (including sepsis with respiratory focus).
- Conditions
- Pneumonia, Bacterial
- Being tested
- procalcitonin
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitoninDiagnostic test
accuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection
| Study group | Role | What they receive |
|---|---|---|
| Procalcitonin algorithm+stewardship team | Experimental | antibiotic prescription guided by PCT values Receives: Diagnostic Test: procalcitonin |
| standard group | No intervention | standard of care guided by current guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Treatment of Pneumonia
Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")
Measured: 30 days
Secondary outcomes (5)
Composite Safety Adverse Event Rate
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
Measured: 30 days
Antibiotic Exposure at Discharge
Duration of antibiotics prescribed at discharge
Measured: 30 days
Days of Therapy Per 1000 Patient Days
Days of therapy per 1000 patient days (inclusive of antibiotics prescribed at discharge)
Measured: 30 days
Length of Stay
Length of stay in hospital
Measured: 30 days
ICU Admissions
Number of Participants Admitted to the ICU
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start28 May 2020
- Primary completion17 Jun 2023
- Study completion17 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BRAHMS GmbH, Thermo Fisher Scientific, Inc
- Responsible party
- Principal investigator, Michael K. Mansour, Massachusetts General Hospital
- Investigators
- Michael K Mansour, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158804
- Sponsor's protocol ID
- 2019P000362
- Acronym
- ProSAVE
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2019
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs
- ClinicalTrials.gov ID
- NCT04158804
- Acronym / sponsor ID
- ProSAVE / 2019P000362
- Conditions
- Pneumonia, Bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- BRAHMS GmbH, Thermo Fisher Scientific, Inc
- Study start
- 28 May 2020 (actual)
- Primary completion
- 17 Jun 2023 (actual)
- Study completion
- 17 Jun 2023 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trials comparing PCT-guided antibiotic algorithms to standard management show a significant reduction in antibiotic exposure without an increase in mortality or treatment failure. Despite this strong evidence from multiple studies a recent prospective multicentric interventional trial in the US fell short of demonstrating antibiotic reductions by PCT-guided antibiotic management. Amongst other limitations the authors of that study concluded that successful implementation of PCT may require closer educational oversight. As such, this study will compare effectiveness and safety of antibiotic prescription guided by a PCT-algorithm via a Stewardship Team over standard guidelines in hospitalized adult patients with suspected or confirmed LRTI (including sepsis with respiratory focus).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procalcitonin algorithm+stewardship team | Experimental | Diagnostic Test: procalcitoninantibiotic prescription guided by PCT values |
| standard group | No intervention | –standard of care guided by current guidelines |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized adult patients ≥ 18 years of age
- Suspected or confirmed pneumonia <28 days at time of admission to the hospital (ED) who are prescribed antibiotics
- Minimum of 2 (two) blood samples available for PCT value assessment within 24 hours of hospitalization
Key exclusion criteria (27 listed)
- Patient has tested positive for SARS-CoV-2
- Non-hospitalized patients
- Patients admitted to home health
- Major surgeries, defined as any procedure in which an incision is made with the exception of superficial procedures (eyes, cornea, skin, dental procedures), organs removed, or normal anatomy altered (e.g. open thoracic, abdominal and/or major orthopedic surgery), in the past 1 month or expected surgical procedure or patient receiving antibiotics for surgical prophylaxis
- Active metastatic cancer or neuroendocrine tumor or liquid tumor and/or on check point inhibitors within 3 months or has signs of mucositis (e.g. mouth lesions or intestinal bleeding)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| procalcitoninaccuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection | Diagnostic test | Procalcitonin algorithm+stewardship team |
Primary outcome
Short Treatment of Pneumonia
Time frame: 30 days
Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")
5 secondary outcomes
Composite Safety Adverse Event Rate
Time frame: 30 days
Antibiotic Exposure at Discharge
Time frame: 30 days
Days of Therapy Per 1000 Patient Days
Time frame: 30 days
Length of Stay
Time frame: 30 days
ICU Admissions
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael K Mansour, MD, PhD principal investigator
Massachusetts General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procalcitonin in people with Pneumonia, Bacterial, run by Massachusetts General Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Treatment of Pneumonia (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.