Trial Outcomes & Findings for Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis (NCT NCT00926497)

NCT ID: NCT00926497

Last Updated: 2009-06-23

Results Overview

Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 121 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2009-06-23

Participant Flow

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

Participant milestones

Measure	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.	Standard Group Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Overall Study STARTED	60	61
Overall Study COMPLETED	60	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Procalcitonin-group n=60 Participants 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 Group n=61 Participants Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters	Total n=121 Participants Total of all reporting groups
Age, Categorical <=18 years	60 Participants n=5 Participants	61 Participants n=7 Participants	121 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment Switzerland	60 participants n=5 Participants	61 participants n=7 Participants	121 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)

Outcome measures

Measure	Procalcitonin-group n=60 Participants 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 Group n=61 Participants Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Antibiotic Treatment for More Than 72 Hours	33 participants	55 participants

PRIMARY outcome

Timeframe: 1 month

Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)

Outcome measures

Measure	Procalcitonin-group n=60 Participants 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 Group n=61 Participants Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Absolute Duration of Antibiotic Therapy	79.1 hours Interval 24.0 to 190.0	101.5 hours Interval 38.0 to 196.0

Adverse Events

Procalcitonin-group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	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.	Standard Group Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Respiratory, thoracic and mediastinal disorders Secondary antibiotic therapy	1.7% 1/60 • Number of events 1	0.00% 0/61

Additional Information

Martin Stocker, MD

Children's Hospital of Lucerne

Phone: 0041412051288

Email: martin.stocker@ksl.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place