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

Phase 2 Completed 13 enrolled Herlev Hospital Bispebjerg Hospital · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2018-02-14
Primary completion: 2018-07-17
Completion: 2018-07-17

Outcome

Met primary endpoint

paper The total LOS was significantly shorter in the intervention group (six participants, median 13 h; range 2-21 h) than in the control group PMID 32432123 ↗

paper p = 0.017. PMID 32432123 ↗

Publications

Fonnes S, Roepstorff S, Holzknecht BJ, Olesen CS, Olsen JHH, Schmidt L, Alder R, Gamborg S, Rasmussen T, Arpi M, Jorgensen LN, Rosenberg J. Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis: A Pivotal Quasi-Randomized Controlled Trial. Front Surg. 2020 May 5;7:25. doi: 10.3389/fsurg.2020.00025. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amoxicillin	Other / unclassified	500 mg	Oral
Subject	Fosfomycin	Small molecule	4 g	Intrathecal
Subject	Metronidazole	Small molecule	500 mg	Intravenous
Subject	Molgramostim	Protein / enzyme biologic	50 ug	Intrathecal
Comparator	Piperacillin	Small molecule	4 g	Intravenous
Comparator	Tazobactam	Small molecule	500 mg	Intravenous
Subject	clavulanic acid	Small molecule	125 mg	Oral