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

NCT ID: NCT01862185

Last Updated: 2014-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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semi-quantitative procalcitonin

patients whom checked semi-quantitative procalcitonin examination

Group Type EXPERIMENTAL

semi-quantitative procalcitonin

Intervention Type OTHER

control

patients whom do not checked semi-quantitative procalcitonin examination

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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semi-quantitative procalcitonin

Intervention Type OTHER

Other Intervention Names

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PCT-Q

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dana Dharaniyadewi

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dana Dharaniyadewi, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Indonesia University

Locations

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Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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AB-PCTQ1

Identifier Type: -

Identifier Source: org_study_id

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