Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT03046758
Eligibility 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
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03046758
Study Brief:
Protocol Section:
NCT03046758