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

Primary Purpose

Sepsis

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

semi-quantitative procalcitonin

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring semiquantitative, procalcitonin, sepsis, antibiotics, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

semi-quantitative procalcitonin

control

Arm Description

patients whom checked semi-quantitative procalcitonin examination

patients whom do not checked semi-quantitative procalcitonin examination

Outcomes

Primary Outcome Measures

mortality rate

mortality in 14 days since the patients were included in this study

Secondary Outcome Measures

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?

the appropriateness of empirical antibiotic

does the empirical antibiotic that given in 24 hours since the patient was diagnosis as sepsis is effective?

Full Information

NCT ID

NCT01862185

First Posted

May 20, 2013

Last Updated

March 6, 2014

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT01862185

Brief Title

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

Official Title

Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

semiquantitative, procalcitonin, sepsis, antibiotics, mortality

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

205 (Actual)

8. Arms, Groups, and Interventions

Arm Title

semi-quantitative procalcitonin

Arm Type

Experimental

Arm Description

patients whom checked semi-quantitative procalcitonin examination

Arm Title

control

Arm Type

No Intervention

Arm Description

patients whom do not checked semi-quantitative procalcitonin examination

Intervention Type

Other

Intervention Name(s)

semi-quantitative procalcitonin

Other Intervention Name(s)

PCT-Q

Primary Outcome Measure Information:

Title

mortality rate

Description

mortality in 14 days since the patients were included in this study

Time Frame

14 days

Secondary Outcome Measure Information:

Title

the timing of empirical antibiotic first dose

Description

when does the patient get their first dose of empirical antibiotic in 24 hours since the patient was diagnosis as sepsis?

Time Frame

in 24 hours since the patient was diagnosis as sepsis

Title

the appropriateness of empirical antibiotic

Description

does the empirical antibiotic that given in 24 hours since the patient was diagnosis as sepsis is effective?

Time Frame

in 24 hours since the patient was diagnosed as sepsis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dana Dharaniyadewi, MD

Organizational Affiliation

Faculty of Medicine, Indonesia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cipto Mangunkusumo Hospital

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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