Intraperitoneal treatment with fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor in patients with multi-quadrant peritonitis undergoing abdominal surgery: A randomized placebo-controlled trial (TRIPLE)
This research, called TRIPLE, is looking into new ways to treat peritonitis, which is a serious infection inside your tummy that often needs surgery. The main goal is to see if giving a special combination of antibiotics (fosfomycin and metronidazole) and a medicine called recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) directly into the tummy during surgery can improve how quickly and well patients recover. Some patients will receive these active medicines, while others will receive a dummy treatment (placebo) to help doctors understand if the new treatment really makes a difference. Researchers will be checking for problems like new infections, further surgery, or needing more antibiotics after the initial operation over a period of 28 days.
At a glance
What is this study about?
This study, called TRIPLE, is for people who have a serious infection inside their belly called peritonitis. Peritonitis happens when the protective lining of your tummy gets infected, often after a burst appendix, a hole in your bowel, or other tummy problems. It's a serious condition that almost always requires surgery.
The doctors in this study want to find out if a new way of giving medicines can help patients recover better after surgery for peritonitis. They are testing a combination of two antibiotics, fosfomycin and metronidazole, along with another medicine called GM-CSF. These medicines will be given directly into the tummy during the surgery. The idea is that treating the infection directly in the belly might work better than just giving medicines through a drip.
To find out if this combination really works, some patients will receive these active medicines, while others will receive a dummy treatment called a placebo. This is a common way to test new treatments, as it helps doctors clearly see if the new medicines are making a difference and are truly better than standard care. The main thing they will be looking for is how well patients recover in the 28 days after surgery – specifically, if they avoid further complications like new infections, needing more surgery, or longer hospital stays.
Key takeaways
- This study evaluates new treatments for serious tummy infections (peritonitis).
- It tests giving special medicines directly into the tummy during surgery.
- The goal is to improve recovery and reduce further problems after surgery.
- Some patients will receive the new medicine, others a dummy treatment.
- Your health will be closely monitored for 28 days after surgery.
- The study aims to find safer and more effective ways to treat peritonitis.
Who may be eligible?
To be able to join this study, you would need to be 18 years old or older. The study is open to both men and women.
The most important requirement is that you have peritonitis, which is a severe infection in your abdomen (tummy), and that you need surgery to treat it. The doctors will determine if your specific situation fits the study's requirements.
There might be other health conditions or medicines you are taking that could prevent you from joining, as the research team needs to make sure the study is safe for everyone involved and that the results will be clear.
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 18 years old or older?
- Do you have peritonitis (a serious tummy infection)?
- Do you need surgery for your peritonitis?
- Are you able to attend follow-up appointments for 28 days after surgery?
What does participation involve?
If you decide to take part in this study, you would first have a meeting with the study team to fully understand what is involved and to make sure it's right for you. If you agree, you will then be randomly assigned to either receive the new combination of medicines during your peritonitis surgery or to receive a dummy treatment (placebo).
After your surgery, the research team will keep a close eye on your recovery for 28 days. This will involve regular checks of your health, taking blood samples to look at different markers like infection levels and general health, and asking you about how you are feeling (using a questionnaire like Quality of Recovery-15). They will also track how long you stay in the hospital, and if you need to be in intensive care. The total duration of active follow-up for the main goals of the study is 28 days, but some general health information might be collected for a bit longer.
Potential risks and benefits
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Common questions
What is peritonitis?
Peritonitis is a very serious infection of the lining inside your tummy. It often needs urgent surgery.
What are 'interventions'?
In this study, 'interventions' are the different medicines being tested and how they are given during surgery.
What does 'randomized placebo-controlled' mean?
It means some patients get the new medicine and some get a dummy treatment, chosen by chance, so doctors can accurately compare the effects.
Why do they take blood samples?
Blood samples help doctors check how your body is responding to the treatment and if there are any changes in your health.
Can I leave the study if I change my mind?
Yes, you can leave the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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