RecruitingPHASE4INTERVENTIONAL

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

This study, called CALIPSO, is investigating the best length of time to give antibiotics (specifically Cefazolin) to patients undergoing heart surgery. The main aim is to prevent infections after surgery, known as surgical site infections. We're comparing three different approaches: giving antibiotics only during the surgery, giving them during surgery and for 24 hours afterwards, or giving them during surgery and for 48 hours afterwards. The study wants to find out if shorter courses of antibiotics are just as effective as longer ones, reducing potential side effects and antibiotic resistance, while still protecting patients from infection. It's a large study involving many hospitals, helping us get clear answers.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Monash University

Enrolment target

9,180

Start

07 Feb 2023

Estimated completion

01 Jun 2028

Surgical Site Infection

What is this study about?

When you have heart surgery, especially one that involves opening the chest bone (sternum), there's a small risk of getting an infection where the cut was made. To help prevent this, doctors give antibiotics. This study, called CALIPSO, is looking into how long people actually need these antibiotics to be effective. For a long time, it's been common to give antibiotics for a day or two after surgery.

The CALIPSO study is a big, important trial trying to find the best approach. It's comparing three different timings for giving a common antibiotic called Cefazolin. One group of patients will receive the antibiotic only while they are having their surgery. Another group will get it during surgery and then for 24 hours (one day) afterwards. The third group will receive it during surgery and then for 48 hours (two days) afterwards. By carefully comparing these groups, doctors hope to learn if giving antibiotics for a shorter time is just as good at preventing infections, without increasing any risks.

Finding the right balance is really important. Using antibiotics for longer than necessary can sometimes lead to side effects or contribute to the problem of antibiotics becoming less effective over time. This study aims to provide clear evidence to help doctors make the best decisions for patients undergoing heart surgery, ensuring they get the right protection against infection with the fewest potential drawbacks.

Key takeaways

Tests how long antibiotics are needed after heart surgery to prevent infections.
Compares antibiotics given only during surgery, versus for 24 hours or 48 hours afterwards.
Aims to find out if shorter antibiotic courses are just as effective and safe.
Could help reduce antibiotic resistance by using antibiotics only when necessary.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

This study is looking for adult patients who are having heart surgery where the breastbone (sternum) is opened down the middle. This is a common type of heart surgery.

However, there are certain situations where you wouldn't be able to join the study. For instance, if you are under 18 years old, or if your kidneys aren't working well (like needing dialysis), you wouldn't be eligible. Also, if your surgery is to treat an existing infection in your heart or breastbone area, or if you've had a strong allergic reaction to the antibiotic Cefazolin before, you wouldn't be able to take part.

Additionally, if you've had certain infections like MRSA in the past year, or if you're having very specific types of heart surgery like a heart transplant or getting certain heart-assist devices, this study wouldn't be right for you. The study also isn't for people who have already been part of this particular CALIPSO trial before.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 or over) having heart surgery?
Will your heart surgery involve opening your breastbone down the middle?
Do you have severe kidney problems or need dialysis?
Is your surgery to treat an existing infection in your heart or chest?
Have you ever had a serious allergic reaction to the antibiotic Cefazolin?
Have you had MRSA in the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the CALIPSO study, you would be randomly assigned to one of three groups. This means it's like flipping a coin to decide if you get antibiotics only during surgery, or for 24 hours, or for 48 hours afterwards. You and your doctors won't know which group you're in, to make sure the results are as fair as possible.

Apart from getting the antibiotic for a specific duration, your surgery and care would generally be the same as usual. The study will mainly involve collecting information about your health and any infections you might get after your surgery. There aren't any extra visits or lengthy assessments beyond what you would normally have for your heart surgery recovery and follow-up. The total duration of your participation would involve tracking your progress after surgery to see if any infections develop.

Potential risks and benefits

The potential benefits of this study include helping to find the safest and most effective way to prevent infections after heart surgery, which could improve care for many patients in the future. For you personally, this means you would receive an antibiotic treatment that is commonly used to prevent infection. All medical treatments carry some risks; for instance, antibiotics can have side effects. If you join the study, some of the antibiotics you receive after surgery might be a placebo (a dummy treatment, which looks like the real thing but has no active drug) if you are in the shorter treatment arms. Researchers will be carefully monitoring your health. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

UT Southwestern Medical Centre
Verified postcode
Dallas, United States· Not yet recruiting
Westmead Hospital
Verified postcode
Sydney, Australia· Recruiting
St George Hospital
Verified postcode
Sydney, Australia· Active not recruiting
The Prince Charles Hospital
Verified postcode
Brisbane, Australia· Recruiting
Princess Alexandra Hospital
Verified postcode
Brisbane, Australia· Recruiting
St Andrew's War Memorial Hospital
Verified postcode
Brisbane, Australia· Active not recruiting
Royal Adelaide Hospital
Verified postcode
Adelaide, Australia· Recruiting
Flinders Medical Centre
Verified postcode
Adelaide, Australia· Recruiting
Flinders Private
Verified postcode
Adelaide, Australia· Recruiting
Royal Hobart Hospital
Verified postcode
Hobart, Australia· Recruiting
The Alfred Hospital
Verified postcode
Melbourne, Australia· Recruiting
The Royal Melbourne Hospital
Verified postcode
Melbourne, Australia· Recruiting

Common questions

What is Cefazolin?

Cefazolin is a common antibiotic used in hospitals to prevent infections, especially after surgery.

What is a 'surgical site infection'?

It's an infection that happens in the area of your body where you had surgery, like where the cut was made after heart surgery.

Will I know if I'm getting a shorter or longer antibiotic course?

No, neither you nor your doctors will know which group you're in. This is called 'double-blind' and helps make the study results fair.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect the medical care you receive.

Why is this study important?

It's important because it aims to find the best way to use antibiotics after heart surgery, hopefully preventing infections while safely reducing antibiotic use.

How to find out more

Paige Druce, MSc(Epi)

paige.druce@monash.edu 9903 0016 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.