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

Klinikum Hanover-Siloah Hospital

Status and phase

Unknown

Phase 4

Conditions

Diverticulitis, Colonic

Acute Disease

Treatments

Drug: ertapenem

Study type

Interventional

Funder types

Other

Identifiers

NCT00097734

INVA-DIV-Study

mc317

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No 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