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Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.
Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.
This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland between June 1, 2005 and December 31, 2006. All term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procalcitonin group | Experimental | Antibiotic therapy is discontinued when two consecutive Procalcitonin values are below predefined age-adjusted cut-off values. Antibiotic therapy could be prolonged despite fulfilled Procalcitonin criteria at the discretion of the attending physician. |
|
| Standard group | No Intervention | Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin-guided decision making | Other | Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Treatment for More Than 72 Hours | Infants treated with antibiotics for more than 72 hours (efficacy of study intervention) | 1 month |
| Absolute Duration of Antibiotic Therapy | Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size) | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Stocker, MD | Children's Hospital Lucerne, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| children's Hospital of Lucerne | Lucerne | 6000 | Switzerland |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Procalcitonin-group | 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. |
| FG001 | Standard Group | Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Procalcitonin-group | 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. |
| BG001 | Standard Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibiotic Treatment for More Than 72 Hours | Infants treated with antibiotics for more than 72 hours (efficacy of study intervention) | Posted | Number | participants | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Procalcitonin-group | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary antibiotic therapy | Respiratory, thoracic and mediastinal disorders | pneumonia | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin Stocker, MD | Children's Hospital of Lucerne | 0041412051288 | martin.stocker@ksl.ch |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Absolute Duration of Antibiotic Therapy | Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size) | Posted | Mean | Full Range | hours | 1 month |
|
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|
|
| 0 |
| 1 |
| EG001 | Standard Group | Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 95 |
| No |
| Superiority or Other |