Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis

Sponsor

Klinikum Hanover-Siloah Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00097734

Collaborator

(none)

540

Enrollment

Location

Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticulitis, Colonic Acute Disease	Drug: ertapenem	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Educational/Counseling/Training

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 Start Date :

Jul 1, 2004

Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Clinical therapeutic success (full regression) []
Relapse rate []
Operation rate []

Secondary Outcome Measures

Development of laboratory parameters []
Duration of hospitalization []
Duration of parenteral feeding []
Incidence of surgical intervention and repeat surgery []
Incidence and duration of intensive care []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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