Catheter-related Bloodstream InfectionPICCORMIDNCT05264402
Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS
An observational study of Catheter-related Bloodstream Infection, run by University Hospital, Brest at 1 site in France.
Trial summary
A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheter-related Bloodstream Infection
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to Nov 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients requiring a vascular approach using PICCline or Midline catheters
Who may be able to join
- Major ≥ 18 years old
- opposition formulated
Who cannot join
- Refusal of participation
- Patients under legal protection (guardianship, curatorship, etc.)
Trial locations and contacts
1 site in 1 country.
Brigitte HUIBAN contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Anais CAILLARD, anais.caillard@chu-brest.fr
About this study
A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.
If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.
The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.
Read the detailed description
This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.
Catheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.
- Conditions
- Catheter-related Bloodstream Infection
- Keywords
- venous access, Midline, PICC line, catheter-related bloodstream infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PICCline group | Patients needing a vascular approach using PICCline catheters | |
| Midline group | Patients needing a vascular approach using Midline catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.
catheter-related bloodstream infections being defined as clinical signs (fever, swelling, pain) associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.
the number of infections recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline
Measured: first 30 days after placement
Secondary outcomes (2)
catheter placement time will be evaluated in days
catheter placement time will be evaluted by measuring the time between catheter placement and removal in days
Measured: first 30 days after placement
rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications
The number of mechanical compliaction (obstruction, accidental removal, etc.), haemorrhagic and thrombotic complications recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline
Measured: first 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start15 Nov 2021
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-related Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264402
- Sponsor's protocol ID
- PICCORMID (29BRC21.0288)
- Acronym
- PICCORMID
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS
- ClinicalTrials.gov ID
- NCT05264402
- Acronym / sponsor ID
- PICCORMID / PICCORMID (29BRC21.0288)
- Conditions
- Catheter-related Bloodstream Infection
- Keywords
- venous access, Midline, PICC line, catheter-related bloodstream infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 3 Mar 2022 (actual)
- 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.
A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.
If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.
The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.
Detailed description
This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.
Catheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICCline group | – | –Patients needing a vascular approach using PICCline catheters |
| Midline group | – | –Patients needing a vascular approach using Midline catheters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a vascular approach using PICCline or Midline catheters
Key inclusion criteria (2 listed)
- Major ≥ 18 years old
- opposition formulated
Key exclusion criteria (2 listed)
- Refusal of participation
- Patients under legal protection (guardianship, curatorship, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.
Time frame: first 30 days after placement
catheter-related bloodstream infections being defined as clinical signs (fever, swelling, pain) associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points. the number of infections recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline
2 secondary outcomes
catheter placement time will be evaluated in days
Time frame: first 30 days after placement
rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications
Time frame: first 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Brigitte HUIBAN contact
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-related Bloodstream Infection, run by University Hospital, Brest at 1 site in France.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Mar 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AnaÏS CAILLARD (02 98 34 72 88, anais.caillard@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points. (time frame: first 30 days after placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.