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Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis

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ClinicalTrials.gov Identifier: NCT00926497
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : June 23, 2009
Last Update Posted : June 23, 2009
Sponsor:
Information provided by:
Luzerner Kantonsspital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sepsis
Intervention Other: Procalcitonin-guided decision making
Enrollment 121
Recruitment Details Between June 1, 2005 and December 31, 2006 all term and near-term infants with a gestational age more than 34 weeks with suspected early-onset sepsis admitted to the Children's Hospital of Lucerne
Pre-assignment Details  
Arm/Group Title Procalcitonin-group Standard Group
Hide Arm/Group Description Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician. Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Period Title: Overall Study
Started 60 61
Completed 60 61
Not Completed 0 0
Arm/Group Title Procalcitonin-group Standard Group Total
Hide Arm/Group Description Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician. Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters Total of all reporting groups
Overall Number of Baseline Participants 60 61 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
<=18 years
60
 100.0%
61
 100.0%
121
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
Female
21
  35.0%
25
  41.0%
46
  38.0%
Male
39
  65.0%
36
  59.0%
75
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 60 participants 61 participants 121 participants
60 61 121
1.Primary Outcome
Title Antibiotic Treatment for More Than 72 Hours
Hide Description Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procalcitonin-group Standard Group
Hide Arm/Group Description:
Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Overall Number of Participants Analyzed 60 61
Measure Type: Number
Unit of Measure: participants
33 55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Procalcitonin-group, Standard Group
Comments The trial was designed to obtain a power of 90% to detect a 30% difference between the two groups in the duration of antibiotic therapy with an estimated standard deviation of 50%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Absolute Duration of Antibiotic Therapy
Hide Description Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procalcitonin-group Standard Group
Hide Arm/Group Description:
Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Overall Number of Participants Analyzed 60 61
Mean (Full Range)
Unit of Measure: hours
79.1
(24 to 190)
101.5
(38 to 196)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Procalcitonin-group, Standard Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Procalcitonin-group, Standard Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Procalcitonin-group Standard Group
Hide Arm/Group Description Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician. Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
All-Cause Mortality
Procalcitonin-group Standard Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Procalcitonin-group Standard Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Procalcitonin-group Standard Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1      0    
Respiratory, thoracic and mediastinal disorders     
Secondary antibiotic therapy  1  1/60 (1.67%)  1 0/61 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, pneumonia
The samll sample size does not allow to prove the safety of our Procalcitonin-guided strategy. Second, because of our single center setting, our results cannot be easily be extrapolated.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin Stocker, MD
Organization: Children's Hospital of Lucerne
Phone: 0041412051288
EMail: martin.stocker@ksl.ch
Layout table for additonal information
Responsible Party: Martin Stocker, MD, Children's Hospital Lucerne
ClinicalTrials.gov Identifier: NCT00926497     History of Changes
Other Study ID Numbers: PCTStocker
First Submitted: January 16, 2009
First Posted: June 23, 2009
Results First Submitted: January 16, 2009
Results First Posted: June 23, 2009
Last Update Posted: June 23, 2009