Catheter-associated Bloodstream Infections (CLABSI)NCT01985737
Catheter Biofilm Microbiome in Infected Neonatal Catheters.
An observational study of Catheter-associated Bloodstream Infections (CLABSI), run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 weeks
- Conditions the study is for
- Catheter-associated Bloodstream Infections (CLABSI)
- What is being tested?
- Sample collection
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2013to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All neonates admitted to Texas Children's Hospital (TCH) NICU with indwelling catheters will be recruited at the time of line insertion.
Who may be able to join
- Neonates with a percutaneously inserted central catheters (Neo PICC) who may or may not develop CLABSIs
Who cannot join
- Infants with known Immunodeficiency Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Sample collection
- Keywords
- Neonatal Intensive Care Units (NICUs), NICUs, Neonates, CLABSI, Microbiome, DNA signature, Catheter infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Also called This is an observational biospecimen collection study.
| Study group | Role | What they receive |
|---|---|---|
| Infants with infected PICC line | After informed consent the subjects that develop a PICC line infection in the NICU will serve as the cases. Receives: Other: Sample collection | |
| 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. Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI
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.
Measured: 1 year
Secondary outcomes (1)
Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study start1 Nov 2013
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter-associated Bloodstream Infections (CLABSI)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Pammi, Baylor College of Medicine
- Investigators
- Mohan Pammi, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985737
- Sponsor's protocol ID
- H-33004
- Other IDs
- Blood Stream Infections
- Status last verified
- Jun 2020
- First submitted
- 11 Nov 2013
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31945114
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofilm Microbiome and Microbial DNA Load in Neonatal Catheter-associated Bloodstream Infections
- ClinicalTrials.gov ID
- NCT01985737
- Acronym / sponsor ID
- H-33004
- Keywords
- Neonatal Intensive Care Units (NICUs), NICUs, Neonates, CLABSI, Microbiome, DNA signature, Catheter infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with infected PICC line | – | Other: Sample collectionAfter informed consent the subjects that develop a PICC line infection in the NICU will serve as the cases. |
| Infants without infected PICC line | – | Other: Sample collectionAfter informed consent the subjects that do not develop a PICC line infection in the NICU will serve as the controls. |
Who may qualify
- Ages
- 1 day to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All neonates admitted to Texas Children's Hospital (TCH) NICU with indwelling catheters will be recruited at the time of line insertion.
Key inclusion criteria (1 listed)
- Neonates with a percutaneously inserted central catheters (Neo PICC) who may or may not develop CLABSIs
Key exclusion criteria (1 listed)
- Infants with known Immunodeficiency Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionAlso: This is an observational biospecimen collection study. | Other | Infants with infected PICC line, Infants without infected PICC line |
Primary outcome
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 secondary outcome
Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Results publication: PubMed 31945114Pammi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Pammi, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-associated Bloodstream Infections (CLABSI), run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01985737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.