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

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ClinicalTrials.gov Identifier: NCT02202941
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
National Evidence-based healthcare Collaborating Agency (NECA)
Asan Medical Center
Samsung Medical Center
Severance Hospital
Information provided by (Responsible Party):
Sang-Min Lee, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sepsis Other: Procalcitonin guided treatment Other: Conventional treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients in Korea
Actual Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Arm Intervention/treatment
Experimental: Procalcitonin guided treatment
Patients who will be randomized to this arm will receive antibiotics therapy based on procalcitonin-guided algorithm.
Other: Procalcitonin guided treatment
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.

Active Comparator: Conventional treatment
Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.
Other: Conventional treatment
Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.




Primary Outcome Measures :
  1. Duration of antibiotic treatment [ Time Frame: up to 28 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202941


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
National Evidence-based healthcare Collaborating Agency (NECA)
Asan Medical Center
Samsung Medical Center
Severance Hospital
Investigators
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Principal Investigator: Sang-Min Lee, M.D. Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sang-Min Lee, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02202941     History of Changes
Other Study ID Numbers: PRODA-2014
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents