Clinical trial NCT01985737: Catheter Biofilm Microbiome in Infected Neonatal Catheters.
Official title: Biofilm Microbiome and Microbial DNA Load in Neonatal Catheter-associated Bloodstream Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter-associated Bloodstream Infections (CLABSI)
Keywords: Neonatal Intensive Care Units (NICUs)
NICUs
Neonates
CLABSI
Microbiome
DNA signature
Catheter infections
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 144
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI
timeFrame: 1 year
Secondary outcomes:
measure: Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Mohan Pammi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.