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

Study Overview
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Brief Summary
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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
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A Prospective, Multicenter, Open-Label, Randomized Clinical Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis

Conditions
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Diverticulitis, Colonic, Acute Disease

Intervention / Treatment
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* Drug: ertapenem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ertapenem|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical therapeutic success (full regression) |  |  | 
| Relapse rate |  |  | 
| Operation rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of laboratory parameters |  |  | 
| Duration of hospitalization |  |  | 
| Duration of parenteral feeding |  |  | 
| Incidence of surgical intervention and repeat surgery |  |  | 
| Incidence and duration of intensive care |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diverticulitis, Invanz, Ertapenem, acute attacks, sigmoid diverticulitis, Acute attacks of sigmoid diverticulitis