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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862185
• Other study ID #: AB-PCTQ1
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2013
• Last updated: March 6, 2014
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sepsis

Intervention

Other:
• semi-quantitative procalcitonin

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate	mortality in 14 days since the patients were included in this study	14 days	No
Secondary	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	No
Secondary	the appropriateness of empirical antibiotic	does the empirical antibiotic that given in 24 hours since the patient was diagnosis as sepsis is effective?	in 24 hours since the patient was diagnosed as sepsis	No