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:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT06841003
Eligibility Criteria:
Inclusion Criteria:
* All patients ≥ 8 years with a preoperative diagnosis of acute appendicitis either with or without clinical or radiological suspicion of CA undergoing a laparoscopic appendectomy for intra-operative confirmed CA that can provide a signed written consent form.
Exclusion Criteria:
* Age under 8 years;
* Not able to give informed consent (language barrier, legally incapable)
* Any contraindication for the use of the study medication:
* Hypersensitivity to clindamycin or to any of the excipients benzyl alcohol, sodium edetate, water, or to lincomycin;
* Hypersensitivity to gentamicin or to sodium metabisulfite: particularly in asthmatic patients, this may trigger bronchospasms and anaphylactic shock or to any of the excipients: disodium edetate, sodium hydroxide, sodium metabisulfite (E223), water for injections;
* Severe sepsis defined as sepsis-induced tissue hypoperfusion or organ dysfunction that includes any of the following thought to be caused by the infection:
* Sepsis-induced hypotension
* Lactate above upper limits laboratory normal
* Urine output \<0.5 mL/kg/h for more than 2h despite adequate fluid resuscitation
* Acute lung injury with PaO2/FiO2 \<250 in the absence of pneumonia as infection source
* Acute lung injury with PaO2/FiO2 \<200 in the presence of pneumonia as infection source
* Creatinine \>2.0 mg/dL (176.8 μmol/L)
* Bilirubin \>2mg/dL (34.2 μmol/L)
* Platelet count \< 100,000 μL
* Coagulopathy (international normalized ratio (INR) \> 1.5);
* ASA IV score;
* Known malignancy;
* Renal dysfunction (i.e. eGFR ≤ 60);
* Immunocompromised patients (i.e. hematological malignancies, HIV/AIDS, bone marrow transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, chemotherapy, dialysis, solid organ transplant, and immunosuppressant use (such as corticosteroids in patients with rheumatoid arthritis));
* Pregnancy;
* Known allergies to either gentamicin or clindamycin;
* Known colonization of bacteria resistant to either gentamicin or clindamycin;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT06841003
Study Brief:
Protocol Section:
NCT06841003