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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)
EU CTIS ID: 2024-520317-49-00
What this study is testing
To investigate if intraperitoneal administration of GM-CSF, metronidazole and fosfomycin can optimize the treatment of patients with multiquadrant peritonitis
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - All patients age ≥ 18 undergoing surgical intervention with findings of peritonitis, due to a lesion in the large intestine, with the involvement of ≥2 quadrants
You likely can't join if
- - Patients with a previous allergic reaction to rhGM-CSF, fosfomycin or metronidazole - Patients with American Society of Anesthesiologists (ASA) physical status >3 - Patients with WHO Performance status >3 - Patients with peritoneal carcinomatosis - Patients currently in treatment for any malignant or hematological disease - Patients active prescribed immunosuppressants - Patients with an autoimmune disease in active treatment with immunomodulatory drugs - Patients with the need of vacuum assisted closure (VAC) - Participating in another pharmacological intervention trial - Patients currently pregnant or breastfeeding. - Patients with severe renal failure (eGFR < 30 ml/min) - Patients with anticipated compliance problems as determined by the investigator
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.