Catheter Biofilm Microbiome in Infected Neonatal Catheters.

NCT ID: NCT01985737

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-01
• Study Completion Date: 2017-04-01

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.

Conditions

Catheter-associated Bloodstream Infections (CLABSI)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Infants with infected PICC line

After informed consent the subjects that develop a PICC line infection in the NICU will serve as the cases.

Sample collection

Intervention Type: OTHER

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.

Sample collection

Intervention Type: OTHER

Interventions

Sample collection

Intervention Type: OTHER

Other Intervention Names

This is an observational biospecimen collection study.

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mohan Pammi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohan Pammi, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31945114 (View on PubMed)

Other Identifiers

Blood Stream Infections

Identifier Type: -

Identifier Source: secondary_id

H-33004

Identifier Type: -

Identifier Source: org_study_id