We intend to investigate the safety of treating secondary infectious peritonitis due to uncomplicated appendicitis with intraperitoneally administered fosfomycin, metronidazole and GM-CSF. MedDRA version: 19.0 Level: LLT Classification code 10000677 Term: Acute appendicitis System Organ Class: 100000004862 MedDRA version: 19.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848
Conditions
Interventions
Product Name: Repomol
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Fosfomycin disodium salt
CAS Number: 26016-99-9
Other descriptive name: FOSFOMYCIN
Concentration unit:
Sponsors
Department of Surgery, Herlev Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men =18 years old Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual appendectomy Written informed consent after written and verbal information 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 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: Cannot understand, read or speak Danish Previous allergic reaction to fosfomycin, metronidazole, or GM-CSF Perforated appendicitis (diagnosed either during surgery or at a preoperative computer tomography (CT) scan) Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy Other intra-abdominal pathology requiring surgical intervention (diagnosed either during surgery or at a preoperative CT-scan) Known renal or hepatic disease or biochemical evidence at the time of admission Known autoimmune disease or other chronic inflammation Known hematologic disease or cancer Previous abdominal surgery (either laparoscopic or open surgery) Daily use or use of medication one week prior to or during the trial period apart from painkillers such as paracetamol, ibuprofen, tramadol, and morphine as well as drugs needed for anaesthesia, thrombosis prophylaxis, and nausea. Limitations for antibiotics are defined below Use of other antimicrobial agents than the trial treatment one month before until 24 hours after the trial treatment Participant in another drug trial one month prior to the date of the surgery Body mass index =35 kg/m2 Weekly intake of alcohol >14 units, where one unit corresponds to 12 g alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The safety of intraperitoneal administration is evaluated through the white blood cell counts 4 hours postoperatively. A toxic effect is defined by a drop below the lower reference range.;Secondary Objective: Repeated biochemical markers (including a white blood cell differential count, inflammation marker C-reactive protein (CRP), kidney function tests, liver function tests, and electrolytes), vital signs (blood pressure, pulse, frequency of respiration, peripheral saturation (SAT), and temperature), length of stay, side effects, and adverse events until 30 days after surgery.;Primary end point(s): Compare preoperative (baseline) with postoperative white blood cell counts. A toxic effect defined by a drop below the reference range.;Timepoint(s) of evaluation of this end point: Preoperatively (baseline) and 4 hours ± 30 minutes postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare preoperative (baseline) with postoperative standard panel of blood samples. Vital signs: Pulse, blood pressure, temperature, frequency of respiration, and SAT. Length of stay in hours postoperatively. Side effects: Evaluated through an objective examination and questions about changes. Adverse events: Registered from the surgery until 30 days postoperatively through medical records and contact with the participant by telephone. ;Timepoint(s) of evaluation of this end point: Blood samples: Preoperatively (baseline) and 4 hours ± 30 minutes postoperatively. Vital values: Measured perioperatively at: Baseline, 5 minutes, 10 minutes and 15 minutes after the trial treatment has been administered and postoperatively at: 4 and 12 hours ± 30 minutes after the trial treatment has been administered. Length of stay: After discharge. Side effects: 12 hours ± 30 minutes and 10 days postoperatively ± 1 day. Adverse events: 30 days postoperatively. | — |
Countries
Denmark
Contacts
Public ContactCPO office
Department of Surgery
Outcome results
None listed