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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Klinikum Hanover-Siloah Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Klinikum Hanover-Siloah Hospital
ClinicalTrials.gov Identifier:
NCT00097734
First received: November 29, 2004
Last updated: February 12, 2006
Last verified: February 2006
History of Changes

November 29, 2004
February 12, 2006
July 2004
 
  • Clinical therapeutic success (full regression)
  • Relapse rate
  • Operation rate
Same as current
Complete list of historical versions of study NCT00097734 on ClinicalTrials.gov 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
 
 
 
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.
 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
  • Diverticulitis, Colonic
  • Acute Disease
Drug: ertapenem
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
540
June 2007
 

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
Both
18 Years to 75 Years
No
Contact: Ferdinand Koeckerling, Prof. Dr. 0049-511-927-2331 ferdinand.koeckerling.siloah@klinikum-hannover.de
Contact: Omar Huegel, Dr. 0049-511-927-2331 Dr.O.Huegel@arcor.de
Germany
 
NCT00097734
mc317, INVA-DIV-Study
 
 
Klinikum Hanover-Siloah Hospital
 
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