Neonatal Procalcitonin Intervention Study (NeoPInS)
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|ClinicalTrials.gov Identifier: NCT00854932|
Recruitment Status : Unknown
Verified March 2016 by Stocker Martin, Luzerner Kantonsspital.
Recruitment status was: Active, not recruiting
First Posted : March 3, 2009
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Other: Procalcitonin-guided decision making||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Procalcitonin-guided Decision Making on Duration of Antibiotic Therapy in Suspected Neonatal Early-onset Sepsis: Multicenter Prospective Randomized Intervention Study|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||August 2016|
Experimental: PCT group
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.Antibiotic therapy can be continued despite fulfilled criteria at the discretion of the attending physician. These divesions from the stopping rules will be reported for further analysis.
Other: Procalcitonin-guided decision making
In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PDT values are within the normal range.
Other Name: Procalcitonin-guided duration of antibiotic therapy
No Intervention: Standard group
The duration of antibiotic treatment in the standard group is based on the attending physician's assessment of the risk of classification: infection unlikely for 36-72 hours, infection possible for 5-7 days, infection probable of proven for 7-21 days depending on clinical course, laboratory values and positive cultures.
- The absolute reduction of the duration of antibiotic therapy with unchanged outcome [ Time Frame: 1 month ]Unchanged outcome = proportion of infants with a recurrence of infection requiering additional courses of antibiotic therapy within 72 hours after ending antibiotic therapy and/or death in the first month of life
- Duration of hospitalisation [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854932
|children's Hospital of Lucerne|
|Lucerne, Switzerland, 6000|
|Principal Investigator:||Martin Stocker, MD||Kantonsspital Luzern, Switzerland|