Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticul… (NCT00097734) | Clinical Trial Compass
UnknownPhase 4
Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
Germany540 participantsStarted 2004-07
Plain-language summary
The purpose of this study is to compare the efficacy (by assessing the clinical success of treatment) of intravenous antibiotic therapy with ertapenem in patients with acute attacks of sigmoid diverticulitis for 4 vs. 7 days.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.