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

NCT01862185 | Completed Phase 3 DMC

• 1 other identifier: AB-PCTQ1
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

semiquantitative; procalcitonin; sepsis; antibiotics; mortality

Outcome Measures

Primary Outcomes (1)

• mortality rate

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

  14 days

Secondary Outcomes (2)

• the timing of empirical antibiotic first dose

  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

Study Arms (2)

semi-quantitative procalcitonin

EXPERIMENTAL

patients whom checked semi-quantitative procalcitonin examination

Other: semi-quantitative procalcitonin

control

NO INTERVENTION

patients whom do not checked semi-quantitative procalcitonin examination

Interventions

semi-quantitative procalcitonin OTHER

Also known as: PCT-Q

semi-quantitative procalcitonin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• post operative patient
• trauma patient
• have obtained prior antibiotic
• refused to participate

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dana Dharaniyadewi, MD

  Faculty of Medicine, Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 24, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

ID (1)