Neonatal Procalcitonin Intervention Study (NeoPInS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Luzerner Kantonsspital
Sponsor:
Collaborators:
Kantonsspital Winterthur KSW
Triemli Hospital
Kantonsspital Graubuenden
University Hospital Inselspital, Berne
Jeroen Bosch Ziekenhuis, s'-Hertogenbosch
VU University Medical Center
Reinier de Graaf Gasthuis Delft
Erasmus Medical Center
Thomayer University Hospital, Prague
Flevo Ziekenhuis, Almere
Atrium Medisch Centrum, Heerlen
Ijssalland Ziekenhuis, Capelle aan den Ijssel
Sint Franciscus Gasthuis
Vlietland Ziekenhuis, Schiedan
McMaster University
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Stocker Martin, Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00854932
First received: March 2, 2009
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Sepsis
Other: Procalcitonin-guided decision making

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Procalcitonin-guided Decision Making on Duration of Antibiotic Therapy in Suspected Neonatal Early-onset Sepsis: Multicenter Prospective Randomized Intervention Study

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • The absolute reduction of the duration of antibiotic therapy with unchanged outcome [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Duration of hospitalisation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1600
Study Start Date: June 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed 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%.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854932

Contacts
Contact: Martin Stocker, MD 0041793736719 stockermartin@mail.com

Locations
Switzerland
children's Hospital of Lucerne Recruiting
Lucerne, Switzerland, 6000
Contact: Martin Stocker, MD    0041793736719    stockermartin@mail.com   
Principal Investigator: Martin Stocker, MD         
Sponsors and Collaborators
Luzerner Kantonsspital
Kantonsspital Winterthur KSW
Triemli Hospital
Kantonsspital Graubuenden
University Hospital Inselspital, Berne
Jeroen Bosch Ziekenhuis, s'-Hertogenbosch
VU University Medical Center
Reinier de Graaf Gasthuis Delft
Erasmus Medical Center
Thomayer University Hospital, Prague
Flevo Ziekenhuis, Almere
Atrium Medisch Centrum, Heerlen
Ijssalland Ziekenhuis, Capelle aan den Ijssel
Sint Franciscus Gasthuis
Vlietland Ziekenhuis, Schiedan
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Martin Stocker, MD Kantonsspital Luzern, Switzerland
  More Information

Publications:
Responsible Party: Stocker Martin, MD, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT00854932     History of Changes
Other Study ID Numbers: NeoPInS
Study First Received: March 2, 2009
Last Updated: May 27, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Luzerner Kantonsspital:
procalcitonin
sepsis
newborn
intervention study

Additional relevant MeSH terms:
Sepsis
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014