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Completed

NCT Number: NCT00926497

Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis

Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.

Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

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Key information

Conditions

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

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

children's Hospital of Lucerne

Lucerne, 6000, Switzerland

About this study

This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland between June 1, 2005 and December 31, 2006. All term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Term and near-term infants with a gestational age of more than 34 weeks
  • Admitted to the Children's Hospital of Lucerne, Switzerland
  • Suspected neonatal early-onset sepsis
  • Antibiotic therapy
  • Parental consent

Exclusion criteria

  • Surgery in the first 3 days of life
  • Severe congenital malformations
  • Chromosomal abnormalities

Treatment and study plan

Procalcitonin-guided decision making

Other

Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis

Primary outcomes

  1. Antibiotic Treatment for More Than 72 Hours

    Time frame: 1 month

    Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)

  2. Absolute Duration of Antibiotic Therapy

    Time frame: 1 month

    Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Official study title

Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Jun 23, 2009
Registry last updated
Jun 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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