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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT05863832
Eligibility Criteria:
Inclusion Criteria:
1. Egyptian male and female patients aged between 18-65 years' old
2. Subjects having pelvi-abdominal infections such as and not limited to: Ulcerative Colitis, Diverticulitis, Cholecystitis and Pelvic Inflammatory Diseases (PID), as oophoritis and salpingo-oophoritis.
3. Subjects during post-operative period for pelvi-abdominal surgery and following IV medication with Metronidazole injection plus third generation cephalosporin.
4. Subjects who are willing to sign Informed Consent Form (ICF) and ready to comply with the protocol for the duration of the study
Exclusion Criteria:
1. Subjects with a history of hypersensitivity to any of the active ingredients of the treatments used
2. Subjects who are receiving or received any other antibiotics during the previous two weeks, rather than IV treatment in the first post-operative 48 hours, mentioned in the protocol
3. Subjects with Pelvi-abdominal infection and performed surgery after failure of oral antibiotics.
4. Subjects having surgeries such as colorectal surgeries.
5. Subjects with any medical condition requiring the usage of the following medications:
* Drugs that induce microsomal liver enzymes, such as Phenytoin or Phenobarbital.
* Drugs that decrease microsomal liver enzymes activity, such as cetrimide.
* Theophylline
* Corticosteroids
* Antacids containing magnesium and aluminum, supplements and other products containing calcium, iron or zinc
* Tizanidine
6. Subjects with uncontrolled diabetes mellitus; FBG \> 200 mg/ml
7. All subjects with renal impairment (S. Creatinine \> 1.5 mg/dL)
8. All subjects with hepatic impairment (Child-Pugh Score B-C)
9. Subjects with liver enzymes (SGOT \& SGPT \> 2 Normal range)
10. Pregnant or breast-feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05863832
Study Brief:
Protocol Section:
NCT05863832