Status:
UNKNOWN
Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
Lead Sponsor:
Klinikum Hanover-Siloah Hospital
Conditions:
Diverticulitis, Colonic
Acute Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 diverti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00097734
Start Date
July 1 2004
End Date
June 1 2007
Last Update
February 14 2006
Active Locations (1)
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1
Klinikum Hannover- Krankenhaus Siloah
Hanover, Germany, 30449