Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated Appendicitis
1 other identifier
interventional
13
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2018
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2018
CompletedStudy Start
First participant enrolled
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2018
CompletedOctober 16, 2018
October 1, 2018
5 months
February 5, 2018
October 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Total length of hospital stay
in hours
From end of surgery until 30-days follow-up
Secondary Outcomes (12)
Gastrointestinal Quality of Life Index (GIQLI)
10 days (±2 days) and 30 days (±3 days) postoperatively
Side effects
Within 24 hours after surgery and 10 days (±2 days) postoperatively
Postoperative complications
From end of surgery until 30-days follow-up
Surgical site infections requiring surgical drainage
From end of surgery until 30-days follow-up
Intraabdominal abscesses requiring drainage
From end of surgery until 30-days follow-up
- +7 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALControl group
ACTIVE COMPARATORInterventions
All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed. Hereafter, the intervention group will receive three days of orally administered antibiotics: 500 mg amoxicillin combined with 125 mg clavulanic acid and 500 mg metronidazole. These doses will be administered three times daily.
4 g piperacillin/500 mg tazobactam and 1 g metronidazole administered intravenously during surgery followed by 4 g piperacillin/500 mg tazobactam and 500 mg metronidazole administered intravenously three times daily for three days.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
- Bispebjerg Hospitalcollaborator
Study Sites (2)
Department of Surgery, Bispebjerg Hospital
Copenhagen, 2400, Denmark
Department of Surgery, Herlev Hospital
Herlev, 2730, Denmark
Related Publications (1)
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.
PMID: 32432123DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD-student
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 19, 2018
Study Start
February 14, 2018
Primary Completion
July 17, 2018
Study Completion
July 17, 2018
Last Updated
October 16, 2018
Record last verified: 2018-10