Study Summary
This trial is testing whether prophylactic antibiotics are better than placebo for patients with pneumonia and inflammation after cardiac arrest outside the hospital.
Eligible Conditions
- Cardiac Arrest
- Pneumonia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 17 Secondary · Reporting Duration: 6 months post-hospital discharge
28 days
ICU-free days during admission
Mechanical ventilator-free days during admission
4 days
Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia
Percentage of Participants with Microbiologically-confirmed Early-onset Pneumonia
6 months post-hospital discharge
13. Percentage of Participants with a Good Functional Outcome at 6 Months Post-hospital Discharge
After the intervention at the time the participant is discharged from the hospital
Percentage of Participants with a Good Functional Outcome at Hospital Discharge
During the intervention and immediately after the intervention until death or ICU discharge
Percentage of Participants who die in the intensive care unit
Month 6
ICU Length of Stay
During the intervention and immediately after the intervention until death or hospital discharge
Percentage of Participants Discharged Home or to Rehabilitation
Percentage of Participants who Die in the Hospital
Percentage of Participants with Clostridioides difficile-associated Diarrhea
Percentage of Participants with Gallbladder disease
Month 6
Hospital Length of Stay
During the intervention and immediately after the intervention until death or hospital transfer
Percentage of Participants Transferred to Another Hospital
Month 6
Percentage of Participants with non-pulmonary infections
Three days
Percentage of Participants with Type One Hypersensitivity Reactions
≥ 4 days
Percentage of Participants with Clinically-diagnosed late-onset pneumonia
Percentage of Participants with Microbiologically-confirmed late-onset pneumonia
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
No prophylaxis (placebo)
1 of 2
Prophylaxis
1 of 2
Active Control
Experimental Treatment
120 Total Participants · 2 Treatment Groups
Primary Treatment: Antibiotic prophylaxis · No Placebo Group · Phase 2
Prophylaxis
Drug
Experimental Group · 1 Intervention: Antibiotic prophylaxis · Intervention Types: DrugNo prophylaxis (placebo)
Drug
ActiveComparator Group · 1 Intervention: Standard of care without prophylaxis · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months post-hospital discharge
Who is running the clinical trial?
University of New EnglandOTHER
15 Previous Clinical Trials
1,775 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
221 Previous Clinical Trials
90,931 Total Patients Enrolled
1 Trials studying Cardiac Arrest
240 Patients Enrolled for Cardiac Arrest
MaineHealthOTHER
64 Previous Clinical Trials
38,556 Total Patients Enrolled
2 Trials studying Cardiac Arrest
339 Patients Enrolled for Cardiac Arrest
David J. GagnonLead Sponsor
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are 18 years of age or older.
References
- Gagnon, David J., Sergey V. Ryzhov, Meghan A. May, Richard R. Riker, Bram Geller, Teresa L. May, Sarah Bockian, et al.. 2022. “Ceftriaxone to Prevent Pneumonia and Inflammation After Cardiac Arrest (PROTECT): Study Protocol for a Randomized, Placebo-controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06127-w.
- Gagnon DJ, Ryzhov SV, May MA, Riker RR, Geller B, May TL, Bockian S, deKay JT, Eldridge A, Van der Kloot T, Lerwick P, Lord C, Lucas FL, Mailloux P, McCrum B, Searight M, Wirth J, Zuckerman J, Sawyer D, Seder DB. Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial. Trials. 2022 Mar 4;23(1):197. doi: 10.1186/s13063-022-06127-w.
- David J. Gagnon 2021. "Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04999592.
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Conditions
Cancer Related
Treatments