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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Klinikum Hanover-Siloah Hospital

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 Type : Interventional  (Clinical Trial)
Enrollment : 540 participants
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 : July 2004
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical therapeutic success (full regression)
  2. Relapse rate
  3. Operation rate

Secondary Outcome Measures :
  1. Development of laboratory parameters
  2. Duration of hospitalization
  3. Duration of parenteral feeding
  4. Incidence of surgical intervention and repeat surgery
  5. Incidence and duration of intensive care


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097734


Contacts
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

Locations
Germany
Klinikum Hannover- Krankenhaus Siloah Recruiting
Hannover, Germany, 30449
Contact: Omar Huegel, Dr.    0049-511-927-2331      
Principal Investigator: Ferdinand Koeckerling, Prof. Dr.         
Sub-Investigator: Omar Huegel, Dr.         
Sub-Investigator: Pascal Geers, Dr.         
Sponsors and Collaborators
Klinikum Hanover-Siloah Hospital
Investigators
Study Chair: Ferdinand Koeckerling, Prof. Dr. Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department

Publications:

ClinicalTrials.gov Identifier: NCT00097734     History of Changes
Other Study ID Numbers: mc317
INVA-DIV-Study
First Posted: November 30, 2004    Key Record Dates
Last Update Posted: February 14, 2006
Last Verified: February 2006

Keywords provided by Klinikum Hanover-Siloah Hospital:
diverticulitis
Invanz
Ertapenem
acute attacks
sigmoid diverticulitis
Acute attacks of sigmoid diverticulitis

Additional relevant MeSH terms:
Diverticulitis
Acute Disease
Diverticulitis, Colonic
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents