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NCT Number: NCT01862185

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semi-quantitative procalcitonin

Other

Other names: PCT-Q

Primary outcomes

  1. mortality rate

    Time frame: 14 days

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

Secondary outcomes

  1. the timing of empirical antibiotic first dose

    Time frame: 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?

  2. the appropriateness of empirical antibiotic

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 24, 2013
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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