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Cephalosporin Antibiotic

Antibiotic Prophylaxis for Shoulder Surgery Infection (PAPA Trial)

N/A

Recruiting

Led By Dominique Rouleau, MD

Research Sponsored by Université de Montréal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years and older

Presenting normal skin on the shoulder aria

Must not have

Active infection at the surgical site or anywhere

Affected shoulder previously received radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year following the surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two different antibiotics for preventing infection in shoulder surgery.

Who is the study for?

This trial is for adults with normal skin on the shoulder area who need primary open shoulder surgery. It's not for those who've used antibiotics or acne treatments in the last three months, have active infections, prior radiotherapy to the shoulder, allergies to study drugs, open fractures, or severe liver or kidney issues.

What is being tested?

The study aims to find out if Ceftriaxone is better than Cefazolin at preventing P. acnes infection during primary shoulder surgery. Participants will receive one of these antibiotics as a preventive measure before their surgery.

What are the potential side effects?

Possible side effects from Cefazolin and Ceftriaxone include allergic reactions, gastrointestinal upset like diarrhea or nausea, blood clotting problems, and rarely serious skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My shoulder skin is healthy and normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections, including at surgery sites.

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My shoulder has been treated with radiation before.

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My condition is life-threatening or could cause me to lose a limb.

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I have a broken bone that is exposed through my skin.

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I do not have liver or kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year following the surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year following the surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year following the surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Skin Biopsy

Secondary study objectives

Infection

Infection #2

Infection #3

+2 more

Side effects data

From 2021 Phase 4 trial • 32 Patients • NCT04218695

12%

Decompensated cirrhosis

Hepatic Failure

Rectus sheath hematoma

Nausea

Pruritus with rash

Possible gastrointestinal bleed

hyperkalemia

UTI

Hepatic Encephalopathy

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CeftriaxoneExperimental Treatment1 Intervention

During an open shoulder surgery, the Ceftriaxone will be administered to some patient. The Ceftriaxone is a third generation cephalosporin. It targets gram positive cocci such as staphylococcus and streptococcus, gram negative bacilli and some anaerobes, including P. acnes. The prophylactic dose is of 2g IV given a minimum of 30 minutes prior to skin incision. It is effective 12h so no other dose is needed during surgery.

Group II: CefazolinActive Control1 Intervention

During an open shoulder surgery, the Cefazolin will be administered to some patient. The Cefazolin is a first generation cephalosporin. It is a beta lactam which targets gram positive cocci and some gram negative bacilli. The INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. The dosage is 2g intravenous if the patient weights less than 120kg or 3g if the patient weights more than 120kg. The dose should be repeated if the procedure lasts for more than three hours or if the blood loss is greater than 1500mL.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ceftriaxone

2019

Completed Phase 4

~9340

0 / 7Eligibility criteria met