The Effect of Semi-quantitative Procalcitonin Assay to Th... | NCT01862185

Studies
The Effect of Semi-quantitative Procalcitonin Assay to The Adequacy of Empirical Antibiotics and Mortality in Septic Patients

NCT01862185

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Mar 7, 2014Estimated

Enrollment

205Actual

Phase

Phase 3

Conditions

Sepsis

Interventions

semi-quantitative procalcitonin

Countries

Indonesia

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

Mar 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

Dec 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

May 20, 2013

First Submission Date that Met QC Criteria

May 22, 2013

First Posted Date

May 24, 2013Estimated

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

Mar 6, 2014

Last Update Posted Date

Mar 7, 2014Estimated

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

Sepsis is a serious clinical condition with a considerable morbidity and mortality. Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The present study aimed to investigate the effect of semi-quantitative PCT test to the empirical antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in septic patients.

The hypothesis of the study are :

There is an effect on mortality between septic patients who do and do not do semi-quantitative PCT examination
There is an effect on empirical antibiotic initiation time between septic patients who do and do not do semi-quantitative PCT examination
There is an effect on appropriateness of empirical antibiotic between septic patients who do and do not do semi-quantitative PCT examination

Study design is randomized diagnostic trial which is also a pragmatic trial.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
semi-quantitative procalcitonin	Experimental	patients whom checked semi-quantitative procalcitonin examination	Other: semi-quantitative procalcitonin
control	No Intervention	patients whom do not checked semi-quantitative procalcitonin examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semi-quantitative procalcitonin	Other		semi-quantitative procalcitonin	PCT-Q

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rate	mortality in 14 days since the patients were included in this study	14 days

Secondary Outcomes

Measure	Description	Time Frame
the timing of empirical antibiotic first dose	when does the patient get their first dose of empirical antibiotic in 24 hours since the patient was diagnosis as sepsis?	in 24 hours since the patient was diagnosis as sepsis
the appropriateness of empirical antibiotic

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged more than 18 years old
have at least two concomitant systemic inflammatory response syndrome criteria
have focal infection
with or without sign of organ hypoperfusion or dysfunction

Exclusion Criteria:

post operative patient
trauma patient
have obtained prior antibiotic
refused to participate

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dana Dharaniyadewi, MD	Faculty of Medicine, Indonesia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo Hospital		Jakarta	DKI Jakarta	10430	Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided