Neonatal Procalcitonin Intervention Study
This trial is active, not recruiting.
|Treatment||procalcitonin-guided decision making|
|Collaborator||Kantonsspital Winterthur KSW|
|Start date||June 2009|
|End date||May 2015|
|Trial size||1600 participants|
|Trial identifier||NCT00854932, NeoPInS|
In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. This study is designed as a multi-center, prospective, randomized intervention trial. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
The absolute reduction of the duration of antibiotic therapy with unchanged outcome
time frame: 1 month
Duration of hospitalisation
time frame: 1 month
Male or female participants up to 3 days old.
Inclusion Criteria: - Term and near term infants with a gestational age > 34 weeks - Suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy - Parental consent Exclusion Criteria: - Surgery in the first week of life - Severe congenital malformations
|Official title||Effect of Procalcitonin-guided Decision Making on Duration of Antibiotic Therapy in Suspected Neonatal Early-onset Sepsis: Multicenter Prospective Randomized Intervention Study|
|Principal investigator||Martin Stocker, MD|
|Description||Detailed description according our pilot study (see reference). This trial is designed to exclude a difference in rate of re-infection or death greater than 2%. Assuming a 2% reinfection/death rate in each group, 770 patients are required for a power of 80% at alpha=0.05. To allow for some unevaluable cases 800 per group will be included. Based on the data of the pilot study (see reference), with a number of 770 per group a difference between mean antibiotic therapy durations of 10 hours can be detected at two-sided alpha of 0.05 with a power of 95%.|
Call for more information