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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01862185

Enrollment

205

Registered

2013-05-24

Start date

2012-12-31

Completion date

2013-04-30

Last updated

2014-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

semiquantitative, procalcitonin, sepsis, antibiotics, mortality

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.

Interventions

OTHERsemi-quantitative procalcitonin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
the timing of empirical antibiotic first dose	in 24 hours since the patient was diagnosis as sepsis	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	in 24 hours since the patient was diagnosed as sepsis	does the empirical antibiotic that given in 24 hours since the patient was diagnosis as sepsis is effective?

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026