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NCT04158804 · ClinicalTrials.gov registry record · NA
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 700
- Enrollment target
NCT04158804: Completed NA study, sponsored by Massachusetts General Hospital.
NCT04158804 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 700 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04158804, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 700 participants
- Enrollment target
Study 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. 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).
Primary Outcome
Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")
Interventions
- DIAGNOSTIC_TEST procalcitonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2023-06-17 |
| Phase | NA |
What the finished NCT04158804 record still lists
NCT04158804 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which procalcitonin is the first listed.
NCT04158804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04158804 about?
NCT04158804 is a clinical study titled "PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT". 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...
What is the current status of trial NCT04158804?
This trial is currently completed. It is a NA study. The enrollment target is 700 participants. The study started on 2020-05-28. Estimated completion is 2023-06-17.
What interventions are being tested in trial NCT04158804?
The interventions under investigation include: procalcitonin (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04158804?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04158804's enrollment target sits among peer trials
700 149th of 2000 higher than 1,850 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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