This trial is active, not recruiting.

Condition catheter-associated bloodstream infections (clabsi)
Treatment sample collection
Sponsor Baylor College of Medicine
Start date November 2013
End date November 2015
Trial size 144 participants
Trial identifier NCT01985737, Blood Stream Infections, H-33004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
After informed consent the subjects that develop a PICC line infection in the NICU will serve as the cases.
sample collection This is an observational biospecimen collection study.
After informed consent the subjects that do not develop a PICC line infection in the NICU will serve as the controls.
sample collection This is an observational biospecimen collection study.

Primary Outcomes

Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI
time frame: 1 year

Secondary Outcomes

Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection
time frame: 1 year

Eligibility Criteria

Male or female participants up to 3 weeks old.

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

Additional Information

Principal investigator Mohan Pammi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.