Abstract
We aimed to investigate the safety of intraperitoneal administration of the combination of fosfomycin, metronidazole, and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) in patients undergoing appendectomy. We conducted a prospective phase II clinical trial in 14 otherwise healthy men suffering from uncomplicated appendicitis. After appendectomy, the trial treatment was administered intraperitoneally and left in the abdominal cavity. Trial treatment consisted of 4 g fosfomycin, 1 g metronidazole, and 50 µg rhGM-CSF in a total volume of 500 ml. Safety was evaluated through white blood cell count where a toxic effect was predefined. We evaluated harms and adverse events, repeated biochemical markers, vital signs, and length of stay. White blood cell count did not drop below the toxic range. The recorded harms were dizziness, discomfort when breathing deeply, no flatus, and bloating. Adverse events included three patients with diarrhoea after discharge and one patient with a hypotensive episode. No serious adverse events or infectious complications occurred. Intraperitoneal administration of fosfomycin, metronidazole, and rhGM-CSF was safe in otherwise healthy men undergoing laparoscopic appendectomy. There were some possible harms and adverse events but we were unable to assess if they were related to anaesthesia, surgery, or the trial treatment.
Highlights
We aimed to investigate the safety of intraperitoneal administration of the combination of fosfomycin, metronidazole, and recombinant human granulocyte-macrophage colony-stimulating factor in patients undergoing appendectomy
Our treatment regimen consisted of the antimicrobial agents fosfomycin and metronidazol, and recombinant human granulocyte-macrophage colony-stimulating factor in combination with source control
We aimed to evaluate the safety of intraperitoneal administration of the combination of fosfomycin, metronidazole, and rhGM-CSF in patients undergoing laparoscopic appendectomy for uncomplicated acute appendicitis in a phase II clinical trial
Summary
We aimed to investigate the safety of intraperitoneal administration of the combination of fosfomycin, metronidazole, and recombinant human granulocyte-macrophage colony-stimulating factor (rhGMCSF) in patients undergoing appendectomy. Trial treatment consisted of 4 g fosfomycin, 1 g metronidazole, and 50 μg rhGM-CSF in a total volume of 500 ml. Intraperitoneal administration of fosfomycin, metronidazole, and rhGM-CSF was safe in otherwise healthy men undergoing laparoscopic appendectomy. There were some possible harms and adverse events but we were unable to assess if they were related to anaesthesia, surgery, or the trial treatment. Our treatment regimen consisted of the antimicrobial agents fosfomycin and metronidazol, and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) in combination with source control. We aimed to evaluate the safety of intraperitoneal administration of the combination of fosfomycin, metronidazole, and rhGM-CSF in patients undergoing laparoscopic appendectomy for uncomplicated acute appendicitis in a phase II clinical trial. We evaluated safety primarily through of the white blood cell count (WBC)
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