Procalcitonin to Shorten Antibiotics Duration in ICU Pati... | NCT01379547

Studies
Procalcitonin to Shorten Antibiotics Duration in ICU Patients

NCT01379547

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 27, 2012Estimated

Enrollment

1,700Estimated

Phase

Phase 3

Conditions

Sepsis

Interventions

Procalcitonin guided antibiotics treatment algorithm
Conventional treatment

Countries

China
Hong Kong
Taiwan

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

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jun 22, 2011

First Posted Date

Jun 23, 2011Estimated

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

Nov 26, 2012

Last Update Posted Date

Nov 27, 2012Estimated

Name	Class
Beijing Chao Yang Hospital	OTHER
Ruijin Hospital	OTHER
Shanghai Jiao Tong University School of Medicine	OTHER
Chongqing Medical University

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 trial is aimed to show that implementation of a procalcitonin-guided antibiotics algorithm may result in shortened antibiotics course in ICU sepsis patients without inferior outcome as compared to the conventional therapy

Detailed Description

The duration of antibiotic therapy in patients with sepsis is largely empirical. An extended treatment course for up to two weeks is a common practice for patients with sepsis in the ICU, despite lack of evidence for this duration of therapy.

Procalcitonin (PCT) is a new biomarker that has high negative predictive value for systemic bacterial infection. The purpose of this trial is to evaluate whether serial PCT measurements can shorten antibiotic treatment duration in patients with sepsis in the ICU.

Specific Aims

To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in ICU sepsis patients
To show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional Treatment	Active Comparator	Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice	Behavioral: Conventional treatment
procalcitonin-guided antibiotics treatment	Experimental	Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin-guided algorithm.	Behavioral: Procalcitonin guided antibiotics treatment algorithm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Procalcitonin guided antibiotics treatment algorithm	Behavioral	Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin measurement on day 5, 7 and 9.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average antibiotics duration		28 days
28-day mortality rate	Safety endpoints	28 days

Secondary Outcomes

Measure	Description	Time Frame
Proportion of antibiotics use in both arms		28 days
Length of ICU stay		90 days
Recurrence of fever within 72 hours of antibiotics discontinuation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with laboratory- or image-confirmed severe infection at admission or during stay in ICU will be eligible for inclusion.

Definition of laboratory- or image-confirmed severe infection:

Two or more of four Signs of Inflammation
- Temperature > 38.3℃ or < 36℃
- Heart rate > 90 beats/min
- Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg
- WBC > 12,000 cells/mm3, < 4000 cells/mm3, or > 10% bands
Initial Procalcitonin > 0.5 ng/mL
Presence of either laboratory or image evidence of infection

Laboratory evidence:

Sign of inflammation in urine, CSF, ascites, pleural effusion or local abscess

Image evidence:

Compatible findings on Chest X ray、ultrasound、CT、or MR image

Exclusion Criteria:

Age less than 20 years
Known pregnancy
Presence of DNR order
Expected ICU stay less than 3 days
Neutropenia (ANC count < 500/mm3)
Specific infections for which long-term antibiotic treatment is strongly recommended: lung abscess or empyema, bacterial meningitis, osteomyelitis, infective endocarditis, local abscess, mediastinitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chien-Chang Lee, MD, MSc	Contact	+886-972-651951		cclee100@gmail.com

Overall Officials

Name	Affiliation	Role
Chien-Chang Lee, MD, MSc	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University	Recruiting	Ürümqi	Xinjiang		China

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes