Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated Appendicitis

Herlev Hospital

Status and phase: Completed; Phase 2

Conditions: Appendicitis Perforated

Treatments: Drug: Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o.; Drug: Standard antibiotics intravenously

Study type: Interventional

Funder types: Other

Identifiers

NCT03435900

HEH-SF-02

Details and patient eligibility

About

The objective of this trial is to evaluate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) followed by oral antibiotic for three days is as effective as the current intravenous antibiotic treatment given during and three days after appendectomy for perforated appendicitis. The primary outcome is the total length of hospital stay, defined as the number of hours in hospital after end of operation and until 30-day follow-up.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual laparoscopic appendectomy
• Perforated appendicitis (diagnosed during surgery by the surgeon)
• Negative p-HCG (women)
• Written informed consent after written and verbal information (preoperatively for the intervention group and postoperatively for the control group)

Exclusion criteria

• Cannot understand, read or speak Danish
• Previous allergic reaction to fosfomycin, metronidazole, rhGM-CSF, or penicillins e.g. piperacillin or amoxicillin
• Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy or appendicitis without perforation
• Other intra-abdominal pathology requiring surgical intervention at the same operation
• Known renal or hepatic disease or biochemical evidence at the time of admission
• Known hematologic disease in current medical treatment
• American Society of Anesthesiologists (ASA) physical status ≥4 (a patient with severe systemic disease that is a constant threat to life)
• Body weight >110 kg
• Surgery converted to open appendectomy
• Anticipated compliance problems

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Intervention group

Experimental group

Treatment:

Drug: Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o.

Control group

Active Comparator group

Treatment:

Drug: Standard antibiotics intravenously