Procalcitonin as a Marker for the Length of Antibiotic Tr... | NCT01155739

Studies
Procalcitonin as a Marker for the Length of Antibiotic Treatment in Peritonitis and Intra-abdominal Infections

NCT01155739

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Dec 19, 2014Estimated

Enrollment

162Actual

Phase

Not provided

Conditions

Secondary or Tertiary Peritonitis

Interventions

Not provided

Countries

Switzerland

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 2014

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

Jun 2009

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jul 23, 2009

First Submission Date that Met QC Criteria

Jul 1, 2010

First Posted Date

Jul 2, 2010Estimated

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 18, 2014

Last Update Posted Date

Dec 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicolas DEMARTINES, professor of surgery, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Not provided

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

Procalcitonin level used for determining length of antibiotic treatment in peritonitis and intra-abdominal infections. Hypothesis is that length of antibiotic use can be shortened by this method.

Detailed Description

Prospective randomized trial

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
procalcitonine monitoring		PCT group: antibiotic use is tailored by serum procalcitonin values, determined every 48houres.
control group		control group: antibiotic use and length of treatment as defined by guidelines

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
antibiotic treatment length, hospitalisation length without antibiotic, infection recurrence, antibiotic cost		at one month and during hospital stay

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

More than 18 yo
Patient requiring surgery for peritonitis or intra-abdominal infection following: perforation, necrosis, previous operation...
Mannheim Peritonitis score > 14
SIRS present
Probability of survival > 72h
Informed consent by patient/relatives

Exclusion Criteria:

No SIRS
Long date corticoid treatment
Immunosuppression
Thyroid medullary carcinoma
Anaphylactic shock
Acute hepatic deficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

hospitalized patients with SIRS due to peritonitis or intra-abdominal infections

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steve Aellen, MD	Department of visceral surgery, university hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Lausanne		Lausanne		1011	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided