Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis

Neonatal Sepsis Clinical Trial

— suPAR  

Official title:

The Plasma Levels of suPAR in Late-onset Neonatal Sepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01294865
• Other study ID #: Ankara University-02
• Secondary ID: Ankara Universit
• Status: Active, not recruiting
• Phase: N/A
• First received: February 11, 2011
• Last updated: February 11, 2011
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2009
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.

Description:

Infection is a leading cause of neonatal morbidity and mortality worldwide. The clinical presentation of neonatal infection is subtle and nonspecific. Microbiologic cultures of clinical specimens, the gold standard for diagnosis, have low sensitivity and are not available in time to influence initial therapy. Therefore, reliable and rapid in vitro tests are needed for early diagnosis and management of infection in neonates. suPAR, secreted from the cells (neutrophils, lymphocytes, macrophages, endothelial cells) has recently been reported to be a potential biomarker for several infection diseases. The levels of suPAR have not been studied in newborn infants yet.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• Infants with late-onset neonatal sepsis

Exclusion Criteria:

• Infants without parents' consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine, Department of Pediatrics	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of suPAR in late-onset neonatal sepsis	Levels of suPAR will be dosed with suspicion of late-onset sepsis diagnosis at day 0 and at the end of the treatment. The evolution and the best cut-off values will be calculated for the diagnosis. Indices of sensibility, specificity, positive predictive value and negative predictive value will be calculated.	three weeks	No
Secondary	Level of plasma C-reactive protein	Plasma C-reactive protein levels to confirm the diagnostic usefulness of suPAR measurements at diagnosis and end of the treatment	three weeks	No
Secondary	the white blood cell count	the white blood cell counts to confirm the diagnostic usefulness of suPAR measurements at diagnosis and end of the treatment	three weeks	No