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

University of Indonesia (UI)

Status and phase: Completed; Phase 3

Conditions: Sepsis

Treatments: Other: semi-quantitative procalcitonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01862185

AB-PCTQ1

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

205 participants in 2 patient groups

semi-quantitative procalcitonin

Experimental group

Description:

patients whom checked semi-quantitative procalcitonin examination

Treatment:

Other: semi-quantitative procalcitonin

control

No Intervention group

Description:

patients whom do not checked semi-quantitative procalcitonin examination