Catheter Biofilm Microbiome in Infected Neonatal Catheters.

June 3, 2020 updated by: Mohan Pammi, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All neonates admitted to Texas Children's Hospital (TCH) NICU with indwelling catheters will be recruited at the time of line insertion.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants with infected PICC line
After informed consent the subjects that develop a PICC line infection in the NICU will serve as the cases.
Other: Sample collection
Other Names:
  • This is an observational biospecimen collection study.
Infants without infected PICC line
After informed consent the subjects that do not develop a PICC line infection in the NICU will serve as the controls.
Other: Sample collection
Other Names:
  • This is an observational biospecimen collection study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Mohan Pammi, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-33004
  • Blood Stream Infections

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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