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

Primary Purpose

Diverticulitis, Colonic, Acute Disease

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ertapenem
Sponsored by
Klinikum Hanover-Siloah Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Diverticulitis, Colonic focused on measuring diverticulitis, Invanz, Ertapenem, acute attacks, sigmoid diverticulitis, Acute attacks of sigmoid diverticulitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinikum Hannover- Krankenhaus SiloahRecruiting

Outcomes

Primary Outcome Measures

Clinical therapeutic success (full regression)
Relapse rate
Operation rate

Secondary Outcome Measures

Development of laboratory parameters
Duration of hospitalization
Duration of parenteral feeding
Incidence of surgical intervention and repeat surgery
Incidence and duration of intensive care

Full Information

First Posted
November 29, 2004
Last Updated
February 12, 2006
Sponsor
Klinikum Hanover-Siloah Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00097734
Brief Title
Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis
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 Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Klinikum Hanover-Siloah Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis, Colonic, Acute Disease
Keywords
diverticulitis, Invanz, Ertapenem, acute attacks, sigmoid diverticulitis, Acute attacks of sigmoid diverticulitis

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ertapenem
Primary Outcome Measure Information:
Title
Clinical therapeutic success (full regression)
Title
Relapse rate
Title
Operation rate
Secondary Outcome Measure Information:
Title
Development of laboratory parameters
Title
Duration of hospitalization
Title
Duration of parenteral feeding
Title
Incidence of surgical intervention and repeat surgery
Title
Incidence and duration of intensive care

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferdinand Koeckerling, Prof. Dr.
Phone
0049-511-927-2331
Email
ferdinand.koeckerling.siloah@klinikum-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Huegel, Dr.
Phone
0049-511-927-2331
Email
Dr.O.Huegel@arcor.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferdinand Koeckerling, Prof. Dr.
Organizational Affiliation
Klinikum Hanover-Siloah hospital and Nordstadt hospital- Surgical Department
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Hannover- Krankenhaus Siloah
City
Hannover
ZIP/Postal Code
30449
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Huegel, Dr.
Phone
0049-511-927-2331
First Name & Middle Initial & Last Name & Degree
Ferdinand Koeckerling, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Omar Huegel, Dr.
First Name & Middle Initial & Last Name & Degree
Pascal Geers, Dr.

12. IPD Sharing Statement

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

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