Catheter Biofilm Microbiome in Infected Neonatal Catheters.

Completed

• Conditions: Catheter-associated Bloodstream Infections (CLABSI)
• Interventions: Other: Sample collection

• Registration Number: NCT01985737
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11-01
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-15
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

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

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Exclusion Criteria

• Infants with known Immunodeficiency Syndrome

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants without infected PICC line	Sample collection	After informed consent the subjects that do not develop a PICC line infection in the NICU will serve as the controls.
Infants with infected PICC line	Sample collection	After informed consent the subjects that develop a PICC line infection in the NICU will serve as the cases.

Primary Outcome Measures

Name	Time	Method
Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection	1 year	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.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States