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Completed

NCT Number: NCT02202941

Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients

This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients with suspicious or confirmed sepsis at admission or during stay in ICU
  • Patients with antibiotic duration of less than 48 hours before enrollment

Exclusion criteria

  • Age less than or equal to 18 years
  • Known pregnancy
  • Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al.
  • severe immunocompromised patients : HIV infected patients (CD4 count < 200 cells/mm3), Neutropenia (ANC count < 500/mm3)
  • Presence of do-not-resuscitate order

Treatment and study plan

Procalcitonin guided treatment

Other

Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.

conventional treatment

Other

Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.

Primary outcomes

  1. Duration of antibiotic treatment

    Time frame: up to 28 days

Secondary outcomes

  1. Clinical response to treatment for infection

    Time frame: up to 28 days

    success vs failure vs relapse after treatment

  2. In ICU mortality

    Time frame: up to 28 days

  3. All cause mortality

    Time frame: up to 28 days

  4. In hospital mortality

    Time frame: up to 90 days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Asan Medical Center
  • National Evidence-Based Healthcare Collaborating Agency
  • Samsung Medical Center
  • Severance Hospital

Registry information

Official study title

Effect of Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients in Korea

Acronym: PRODA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 29, 2014
Registry last updated
Nov 2, 2018

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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