Catheter Biofilm Microbiome in Infected Neonatal Catheters.

Catheter-associated Bloodstream Infections (CLABSI) Clinical Trial

Official title:

Biofilm Microbiome and Microbial DNA Load in Neonatal Catheter-associated Bloodstream Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985737
• Other study ID #: H-33004
• Secondary ID: Blood Stream Inf
• Status: Completed
• Start date: November 1, 2013
• Est. completion date: April 1, 2017

Study information

• Verified date: June 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into blood vessels of premature babies (neonates) to give them nutrition and medications. Sometimes these tubes get infected and they need to be removed. Also, the babies need to be given medications to treat these infections (antibiotics). PICC infections in neonates are a serious problem and we need to find new ways of detecting infections early so that we can treat them promptly to avoid complications.

The purpose of this study is to understand what causes tube infections in neonates and to develop a test to detect tube infections early to avoid complications.

Description:

Catheter-associated bloodstream infections (CLABSIs) are a significant component of healthcare-associated infections (HAI),which are associated with significant mortality, morbidity and healthcare costs. Neonates are at higher risk for CLABSIs than children or adults and CLABSIs are seen more commonly in neonatal than pediatric or adult intensive care units. Neonates, who develop CLABSIs, are not only at serious risk for mortality but also long term neurodevelopmental impairment. CLABSIs are often caused by organisms colonizing the skin and the most frequently isolated organisms are CONS, S. aureus and Candida.

The catheter biofilm microbiome, to our knowledge has not been investigated before. Evaluation of biofilm microbial signatures and microbial DNA load is a novel strategy that may permit earlier diagnosis of CLABSIs. Earlier detection may enable earlier targeted therapy such as antimicrobial lock solutions and may facilitate preservation of catheters in this vulnerable population. Catheter microbial DNA signatures or load may be useful biomarkers to not only predict or diagnose infections but to monitor antibiotic therapy and to confirm resolution of infection.

We will study 15 percutaneously inserted central catheters (PICC) each from neonates with CLABSIs and those without. We will evaluate the bacterial microbiome by profiling V3-5 region of the 16S rDNA, by PCR and pyrosequencing. We will correlate the catheter biofilm microbiome with catheter tip cultures and the skin microbiome at the catheter entry site. We aim to identify microbial signatures that predispose to dissemination of infection from catheter biofilms leading to CLABSIs. Further, we will quantify microbial DNA load in blood from the catheters at the time of removal, by real-time PCR of the bacterial 16S rDNA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Weeks

Eligibility

Inclusion Criteria:

• Neonates with a percutaneously inserted central catheters (Neo PICC) who may or may not develop CLABSIs

Exclusion Criteria:

• Infants with known Immunodeficiency Syndrome

Related Conditions & MeSH terms

• Catheter-associated Bloodstream Infections (CLABSI)
• Infection

Intervention

Other:
• Sample collection

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pammi M, Thapa S, Balderas M, Runge JK, Venkatachalam A, Luna RA. Microbiome signatures in neonatal central line associated bloodstream infections. PLoS One. 2020 Jan 16;15(1):e0227967. doi: 10.1371/journal.pone.0227967. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI	We will study catheters from neonates with CLABSIs and those without. We will correlate the catheter biofilm microbiome with catheter tip cultures and the skin microbiome at the catheter entry site.	1 year
Secondary	Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection	We will determine microbial DNA load in blood from the catheters at the time of removal, by real-time PCR of the bacterial 16S rDNA.	1 year