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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00097734
Eligibility Criteria:
Inclusion Criteria:
* At least three of the following signs or symptoms of an acute attack of sigmoid diverticulitis must be present: \*Fever (body temperature \> 38°C, sublingual), \*Abdominal tenderness, \*Leukocytosis (leukocytes \> 10,000/µl) and left shift of the differential blood count (\>1% band forms), \*Elevated CRP (\> 20 mg/l)
* Evidence of sigmoid diverticulitis by contrast enema
* CT evidence of wall thickening in the sigmoid intestine
* Decision in favor of conservative therapy on the basis of the case history and diagnosis
Exclusion Criteria:
* Contraindication for the use of the study medication or other beta-lactam antibiotics, e.g. patients with advanced renal impairment or patients requiring hemodialysis
* Antibiotic therapy in the two weeks prior to the start of the study
* Patients with an advanced incurable disease
* Patients with a hematologic/oncologic disease (leukemia, lymphoma)
* Patients on immunosuppressants
* Complications of sigmoid diverticulitis leading to an immediate indication for surgery
* Patients who have hypersensitivity to beta-lactam antibiotics
* Female patients who are pregnant or nursing or who could become pregnant during the study
* Participation in another clinical study or use of another study drug within the four weeks prior to enrollment in the study or use of another drug during the study
* Each patient can be enrolled only once in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00097734
Study Brief:
Protocol Section:
NCT00097734