The Safety and Pharmacokinetics of Intraperitoneal Administration in Patients Undergoing Appendectomy for Uncomplicated Appendicitis

Herlev Hospital

Status and phase: Completed; Phase 2

Conditions: Appendicitis

Treatments: Drug: A combination of fosfomycin, metronidazole and GM-CSF i.p.

Study type: Interventional

Funder types: Other

Identifiers

NCT03046758

HEH-SF-01

Details and patient eligibility

About

The objective of this trial is to evaluate the safety of the intraperitoneal administration of the combination of fosfomycin, metronidazole, and granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients undergoing surgery for uncomplicated appendicitis. Further, in a sub-trial the aim is to investigate the plasma concentrations of fosfomycin and metronidazole after intraperitoneal administration.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men ≥18 years old
• Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual appendectomy
• Written informed consent after written and verbal information

Exclusion criteria

• Cannot understand, read or speak Danish
• Previous allergic reaction to fosfomycin, metronidazole, or GM-CSF
• Perforated appendicitis (diagnosed either during surgery or at a preoperative computer tomography (CT) scan)
• Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy
• Other intra-abdominal pathology requiring surgical intervention (diagnosed either during surgery or at a preoperative CT-scan)
• Known renal or hepatic disease or biochemical evidence at the time of admission
• Known autoimmune disease or other chronic inflammation
• Known hematologic disease or cancer
• Previous abdominal surgery (either laparoscopic or open surgery)
• Daily use or use of medication one week prior to or during the trial period apart from painkillers such as paracetamol, ibuprofen, tramadol, and morphine as well as drugs needed for anaesthesia, thrombosis prophylaxis, and nausea. Limitations for antibiotics are defined below
• Use of other antimicrobial agents than the trial treatment one month before until 24 hours after the trial treatment
• Participant in another drug trial one month prior to the date of the surgery
• Body mass index ≥35 kg/m2
• Weekly intake of alcohol >14 units, where one unit corresponds to 12 g alcohol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Participants

Experimental group

Treatment:

Drug: A combination of fosfomycin, metronidazole and GM-CSF i.p.