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

Condition(s) targeted: Diverticulitis, Colonic; Acute Disease

Intervention: ertapenem (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Klinikum Hanover-Siloah Hospital

Official(s) and/or principal investigator(s):
Ferdinand Koeckerling, Prof. Dr., Study Chair, Affiliation: Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department

Overall contact:
Ferdinand Koeckerling, Prof. Dr., Phone: 0049-511-927-2331, Email: ferdinand.koeckerling.siloah@klinikum-hannover.de

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.

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Primary outcome:

Clinical therapeutic success (full regression)

Relapse rate

Operation rate

Secondary outcome:

Development of laboratory parameters

Duration of hospitalization

Duration of parenteral feeding

Incidence of surgical intervention and repeat surgery

Incidence and duration of intensive care

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Ferdinand Koeckerling, Prof. Dr., Phone: 0049-511-927-2331, Email: ferdinand.koeckerling.siloah@klinikum-hannover.de

Klinikum Hannover- Krankenhaus Siloah, Hannover 30449, Germany; Recruiting
Omar Huegel, Dr., Phone: 0049-511-927-2331
Ferdinand Koeckerling, Prof. Dr., Principal Investigator
Omar Huegel, Dr., Sub-Investigator
Pascal Geers, Dr., Sub-Investigator

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Starting date: July 2004
Last updated: February 12, 2006