Antibiotic Therapy of Acute Uncomplicated Colonic Diverti... | NCT01008488

Studies
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

NCT01008488

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Dec 23, 2011Estimated

Enrollment

600Actual

Phase

Not Applicable

Conditions

Colonic Diverticulitis

Interventions

Antibiotic

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

May 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 4, 2009

First Submission Date that Met QC Criteria

Nov 4, 2009

First Posted Date

Nov 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2011

Last Update Posted Date

Dec 23, 2011Estimated

Name	Class
Landstinget i Värmland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis.

The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications.

The patients will be randomized to conservative treatment with and without antibiotic therapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antibiotic	Active Comparator		Drug: Antibiotic
No antibiotic	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibiotic	Drug	Antibiotic according to local treatment routine against bowel pathogenesis	Antibiotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
discharge without complications +/- antibiotic therapy		Within 30 days after discharge

Secondary Outcomes

Measure	Description	Time Frame
to evaluate length of hospital stay, cost and late complications		one year after admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults with CT sign of acute colonic uncomplicated diverticulitis
elevated CRP and LPK
Temp.38c or more

Exclusion Criteria:

patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
pregnancy
immunological incompetence and immunosuppressive therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Smedh	Center of Clinical Research, Västerås	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Central Hospital		Västerås	Västmanland County		Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22290281	Derived	Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.

ID	Term
D004239	Diverticulitis, Colonic
D000076385	Diverticular Diseases

ID	Term
D004238	Diverticulitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses