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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT03380793
Eligibility Criteria:
Inclusion Criteria:
* 18 and 65 years old
* A diagnosis of suppurative or gangrenous appendicitis based on:
1. metastatic right lower abdominal pain
2. lower abdominal tenderness and/or rebound tenderness
3. pyrexia (axillary temperature ≥ 37.5 °C), a WBC \> 10\*109/L on routine blood examination
4. Voluntary signing of written informed consent
Exclusion Criteria:
* patients with an allergy to nitroimidazole
* patients with a history of antibiotic therapy within the last 48 hours
* patients with any condition likely to require broad spectrum antibiotics
* patients who can not evaluate the efficacy or difficult to complete the desired course of treatment
* ALT and / or AST ≥ 1.5 times the ULN, and / or serum creatinine ≥ the ULN
* patients with severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy)
* patients with other diseases or use other drugs which may interfere with the efficacy or safety of the drug
* patients who participated other clinical trials within 6 months before the start of the trial
* Pregnant women, breastfeeding women, women of childbearing age without effective contraceptive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03380793
Study Brief:
Protocol Section:
NCT03380793