The safety and blood concentration measurements of antibiotics after treatment with antibiotics and a drug, which stimulates the immune response, administrated in the abdominal cavity in patients undergoing appendectomy for appendicitis without perforatio

Phase 1

• Conditions: 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: 19.0Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 100000004848; MedDRA version: 19.0Level: LLTClassification code 10000677Term: Acute appendicitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-005772-16-DK
• Lead Sponsor: Department of Surgery, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-19
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 14

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Compare preoperative (baseline) with postoperative standard panel of blood samples.<br>Vital signs: Pulse, blood pressure, temperature, frequency of respiration, and SAT. <br>Length of stay in hours postoperatively.<br>Side effects: Evaluated through an objective examination and questions about changes.<br>Adverse events: Registered from the surgery until 30 days postoperatively through medical records and contact with the participant by telephone.<br>;Timepoint(s) of evaluation of this end point: Blood samples: Preoperatively (baseline) and 4 hours ± 30 minutes postoperatively.<br>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.<br>Length of stay: After discharge.<br>Side effects: 12 hours ± 30 minutes and 10 days postoperatively ± 1 day.<br>Adverse events: 30 days postoperatively.