Clinical trial NCT00097734: Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
Official title: A Prospective, Multicenter, Open-Label, Randomized Clinical Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diverticulitis, Colonic
Acute Disease
Keywords: diverticulitis
Invanz
Ertapenem
acute attacks
sigmoid diverticulitis
Acute attacks of sigmoid diverticulitis
Lead sponsor: Klinikum Hanover-Siloah Hospital
Sponsor class: OTHER
First posted: 2004-11-30
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.


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

Primary outcomes:
measure: Clinical therapeutic success (full regression)
measure: Relapse rate
measure: Operation rate
Secondary outcomes:
measure: Development of laboratory parameters
measure: Duration of hospitalization
measure: Duration of parenteral feeding
measure: Incidence of surgical intervention and repeat surgery
measure: Incidence and duration of intensive care
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Klinikum Hannover- Krankenhaus Siloah
Study officials:
affiliation: Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department
name: Ferdinand Koeckerling, Prof. Dr.
role: STUDY_CHAIR
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