Acute Disease, Diverticulitis, Colonic
Conditions
Keywords
diverticulitis, Invanz, Ertapenem, acute attacks, sigmoid diverticulitis, Acute attacks of sigmoid diverticulitis
Brief 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.
Interventions
DRUGertapenem
Sponsors
Klinikum Hanover-Siloah Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical therapeutic success (full regression) | — |
| Relapse rate | — |
| Operation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Development of laboratory parameters | — |
| Duration of hospitalization | — |
| Duration of parenteral feeding | — |
| Incidence of surgical intervention and repeat surgery | — |
| Incidence and duration of intensive care | — |
Countries
Germany
Contacts
Primary ContactFerdinand Koeckerling, Prof. Dr.
Backup ContactOmar Huegel, Dr.
Outcome results
None listed