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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097734
Recruitment Status : Unknown
Verified February 2006 by Klinikum Hanover-Siloah Hospital.
Recruitment status was:  Recruiting
First Posted : November 30, 2004
Last Update Posted : February 14, 2006
Information provided by:
Klinikum Hanover-Siloah Hospital

November 29, 2004
November 30, 2004
February 14, 2006
July 2004
Not Provided
  • Clinical therapeutic success (full regression)
  • Relapse rate
  • Operation rate
Same as current
Complete list of historical versions of study NCT00097734 on Archive Site
  • Development of laboratory parameters
  • Duration of hospitalization
  • Duration of parenteral feeding
  • Incidence of surgical intervention and repeat surgery
  • Incidence and duration of intensive care
Same as current
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Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
A Prospective, Multicenter, Open-Label, Randomized Clinical Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
  • Diverticulitis, Colonic
  • Acute Disease
Drug: ertapenem
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Klinikum Hanover-Siloah Hospital
Not Provided
Study Chair: Ferdinand Koeckerling, Prof. Dr. Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department
Klinikum Hanover-Siloah Hospital
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP