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Antibiotic
Antibiotics for Pneumonia After Cardiac Arrest (PROTECT Trial)
Phase 2
Recruiting
Research Sponsored by David J. Gagnon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Comatose (do not follow simple verbal commands)
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-hospital discharge
Awards & highlights
PROTECT Trial Summary
This trial is testing whether prophylactic antibiotics are better than placebo for patients with pneumonia and inflammation after cardiac arrest outside the hospital.
Who is the study for?
The PROTECT trial is for adults over 18 who are comatose after a cardiac arrest outside the hospital, regardless of their initial heart rhythm. It's not for those with infections before the cardiac event, on antibiotics already, or with terminal diseases reducing survival chances. People allergic to beta-lactam antibiotics or under legal guardianship/prisoner status are also excluded.Check my eligibility
What is being tested?
This study tests if giving Ceftriaxone (an antibiotic) right after a cardiac arrest can prevent pneumonia and inflammation compared to standard care without prophylaxis. Participants will be randomly assigned to receive either Ceftriaxone or placebo in addition to regular treatment.See study design
What are the potential side effects?
Ceftriaxone may cause side effects like allergic reactions in people sensitive to cephalosporins or penicillins, digestive issues such as diarrhea, potential blood disorders like anemia, and rarely severe skin reactions.
PROTECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot follow simple instructions due to being in a coma.
Select...
I am 18 years old or older.
PROTECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia
Secondary outcome measures
13. Percentage of Participants with a Good Functional Outcome at 6 Months Post-hospital Discharge
Hospital Length of Stay
ICU Length of Stay
+14 morePROTECT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ProphylaxisExperimental Treatment1 Intervention
Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days.
Group II: No prophylaxis (placebo)Active Control1 Intervention
Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted.
Administer antibiotics in response to infection.
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Who is running the clinical trial?
David J. GagnonLead Sponsor
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
248,690 Total Patients Enrolled
1 Trials studying Cardiac Arrest
240 Patients Enrolled for Cardiac Arrest
MaineHealthOTHER
71 Previous Clinical Trials
49,187 Total Patients Enrolled
2 Trials studying Cardiac Arrest
339 Patients Enrolled for Cardiac Arrest
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experienced a heart attack while in the hospital.You have a current infection noted in your medical records.I cannot follow simple instructions due to being in a coma.You have an illness that is expected to make you unlikely to survive for at least 180 days.I am 18 years old or older.I had a bacterial infection before being admitted to the hospital.I was taking antibiotics for an infection before being admitted.Your family or someone acting on your behalf confirms that you have an ongoing infection.I have had emergency heart bypass surgery.I had signs of an infection before my sudden cardiac arrest.You have had a serious allergic reaction to certain antibiotics called beta-lactams, like cephalosporins or penicillins.I have been diagnosed with MRSA or VRE infection.You have any type of abnormal heart rhythm.People who have experienced an out-of-hospital cardiac arrest, including those in the emergency department.
Research Study Groups:
This trial has the following groups:- Group 1: Prophylaxis
- Group 2: No prophylaxis (placebo)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients needed for this research project?
"Yes, this clinical trial is recruiting patients as of now. The latest update on the progress of recruitment was on September 22nd, 2022 and the original posting date was August 20th, 2021."
Answered by AI
How many individuals are taking part in this research project?
"Yes, this is an ongoing trial that is currently seeking participants. According to the listing on clinicaltrials.gov, the study was first posted on 8/20/2021 and was last updated on 9/22/2022. They are looking for 120 patients at 1 site."
Answered by AI
Does the FDA endorse using antibiotics as a preventative measure?
"There is some data supporting the safety of antibiotic prophylaxis, but none yet demonstrating its efficacy. Therefore, it received a score of 2."
Answered by AI
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