Neonatal Procalcitonin Intervention Study

Sepsis Clinical Trial

— NeoPInS  

Official title:

Effect of Procalcitonin-guided Decision Making on Duration of Antibiotic Therapy in Suspected Neonatal Early-onset Sepsis: Multicenter Prospective Randomized Intervention Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00854932
• Other study ID #: NeoPInS
• Status: Active, not recruiting
• Phase: N/A
• First received: March 2, 2009
• Last updated: March 4, 2016
• Start date: June 2009
• Est. completion date: August 2016

Study information

• Verified date: March 2016
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: August 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Switzerland	children's Hospital of Lucerne	Lucerne

Sponsors (17)

Lead Sponsor

Collaborator

Luzerner Kantonsspital

Atrium Medisch Centrum, Heerlen, Erasmus Medical Center, Flevo Ziekenhuis, Almere, Ijssalland Ziekenhuis, Capelle aan den Ijssel, Jeroen Bosch Ziekenhuis, s'-Hertogenbosch, Kantonsspital Graubuenden, Kantonsspital Winterthur KSW, McMaster University, Reinier de Graaf Gasthuis Delft, Sint Franciscus Gasthuis, St. Joseph's Healthcare Hamilton, Thomayerova Teaching Hospital, Triemli Hospital, University Hospital Inselspital, Berne, Vlietland Ziekenhuis, VU University Medical Center

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Stocker M, Fontana M, El Helou S, Wegscheider K, Berger TM. Use of procalcitonin-guided decision-making to shorten antibiotic therapy in suspected neonatal early-onset sepsis: prospective randomized intervention trial. Neonatology. 2010;97(2):165-74. doi: 10.1159/000241296. Epub 2009 Sep 24. — View Citation

Stocker M, Hop WC, van Rossum AM. Neonatal Procalcitonin Intervention Study (NeoPInS): Effect of Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early-onset sepsis: A multi-centre randomized superiority and non-inferiority Intervention Study. BMC Pediatr. 2010 Dec 8;10:89. doi: 10.1186/1471-2431-10-89. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute reduction of the duration of antibiotic therapy with unchanged outcome	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	1 month	Yes
Secondary	Duration of hospitalisation		1 month	Yes