Sepsis
Conditions
Keywords
antibiotic therapy, early-onset sepsis, interventions study, procalcitonin, term and near-term neonates
Brief summary
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.
Detailed description
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.
Interventions
Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis
Sponsors
Luzerner Kantonsspital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No
Inclusion criteria
* Term and near-term infants with a gestational age of more than 34 weeks * Admitted to the Children's Hospital of Lucerne, Switzerland * Suspected neonatal early-onset sepsis * Antibiotic therapy * Parental consent
Exclusion criteria
* Surgery in the first 3 days of life * Severe congenital malformations * Chromosomal abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic Treatment for More Than 72 Hours | 1 month | Infants treated with antibiotics for more than 72 hours (efficacy of study intervention) |
| Absolute Duration of Antibiotic Therapy | 1 month | Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size) |
Countries
Switzerland
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Standard Group Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters | 61 |
| Total | 121 |
Baseline characteristics
| Characteristic | Procalcitonin-group | Standard Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 60 Participants | 61 Participants | 121 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Switzerland | 60 participants | 61 participants | 121 participants |
| Sex: Female, Male Female | 21 Participants | 25 Participants | 46 Participants |
| Sex: Female, Male Male | 39 Participants | 36 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / — | 0 / — |
| serious Total, serious adverse events | 0 / — | 0 / — |
Outcome results
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)
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Procalcitonin-group | Absolute Duration of Antibiotic Therapy | 79.1 hours |
| Standard Group | Absolute Duration of Antibiotic Therapy | 101.5 hours |
p-value: 0.012t-test, 2 sided
p-value: 0.004Wilcoxon (Mann-Whitney)
Primary
Antibiotic Treatment for More Than 72 Hours
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Procalcitonin-group | Antibiotic Treatment for More Than 72 Hours | 33 participants |
| Standard Group | Antibiotic Treatment for More Than 72 Hours | 55 participants |
Comparison: 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%.p-value: 0.002Fisher Exact