Neonatal Procalcitonin Intervention Study

NCT00854932 | Unknown DMC

• 1 other identifier: NeoPInS
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

procalcitonin; sepsis; newborn; intervention study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Duration of hospitalisation

  1 month

Study Arms (2)

PCT group

EXPERIMENTAL

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

Standard group

NO INTERVENTION

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.

Interventions

Procalcitonin-guided decision making OTHER

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.

Also known as: Procalcitonin-guided duration of antibiotic therapy

PCT group

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Surgery in the first week of life
• Severe congenital malformations

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Kantonsspital Winterthur KSW: collaborator
• Triemli Hospital: collaborator
• Kantonsspital Graubuenden: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Jeroen Bosch Ziekenhuis, s'-Hertogenbosch: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Reinier de Graaf Groep: collaborator
• Erasmus Medical Center: collaborator
• Thomayer University Hospital: collaborator
• Flevo Ziekenhuis, Almere: collaborator
• Atrium Medisch Centrum, Heerlen: collaborator
• Ijssalland Ziekenhuis, Capelle aan den Ijssel: collaborator
• Sint Franciscus Gasthuis: collaborator
• Vlietland Ziekenhuis: collaborator
• McMaster University: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

children's Hospital of Lucerne

Lucerne, 6000, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 19776651 BACKGROUND

• 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.

  PMID: 21143869 BACKGROUND

• Stocker M, Daunhawer I, van Herk W, El Helou S, Dutta S, Schuerman FABA, van den Tooren-de Groot RK, Wieringa JW, Janota J, van der Meer-Kappelle LH, Moonen R, Sie SD, de Vries E, Donker AE, Zimmerman U, Schlapbach LJ, de Mol AC, Hoffmann-Haringsma A, Roy M, Tomaske M, Kornelisse RF, van Gijsel J, Plotz FB, Wellmann S, Achten NB, Lehnick D, van Rossum AMC, Vogt JE. Machine Learning Used to Compare the Diagnostic Accuracy of Risk Factors, Clinical Signs and Biomarkers and to Develop a New Prediction Model for Neonatal Early-onset Sepsis. Pediatr Infect Dis J. 2022 Mar 1;41(3):248-254. doi: 10.1097/INF.0000000000003344.

  PMID: 34508027 DERIVED

• Stocker M, van Herk W, El Helou S, Dutta S, Fontana MS, Schuerman FABA, van den Tooren-de Groot RK, Wieringa JW, Janota J, van der Meer-Kappelle LH, Moonen R, Sie SD, de Vries E, Donker AE, Zimmerman U, Schlapbach LJ, de Mol AC, Hoffman-Haringsma A, Roy M, Tomaske M, Kornelisse RF, van Gijsel J, Visser EG, Willemsen SP, van Rossum AMC; NeoPInS Study Group. Procalcitonin-guided decision making for duration of antibiotic therapy in neonates with suspected early-onset sepsis: a multicentre, randomised controlled trial (NeoPIns). Lancet. 2017 Aug 26;390(10097):871-881. doi: 10.1016/S0140-6736(17)31444-7. Epub 2017 Jul 12.

  PMID: 28711318 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Stocker, MD

  Kantonsspital Luzern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2016
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

CH (1)