Antibiotic agents administrated in the abdominal cavity compared with antibiotic agents administrated intravenously for treatment of perforated appendicitis

Phase 1

• Conditions: We wish to investigate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and 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.; MedDRA version: 20.0Level: LLTClassification code 10000680Term: Acute appendicitis without mention of peritonitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-004753-16-DK
• Lead Sponsor: Department of Surgery, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-29
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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 at Herlev Hospital and postoperatively at Bispebjerg Hospital)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified