Catheter Associated InfectionTHROMBI-CATHNCT07388381
Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences
A study testing Follow-up for catheter-related bacteremia in people with Catheter Associated Infection, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The use of long-term peripheral venous catheters inserted in the upper limb (PICC lines and Midlines) has increased markedly over recent years. Catheter-related bacteremias and venous thromboses are the main complications associated with these catheters. These events may occur independently or simultaneously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Associated Infection
- What is being tested?
- Follow-up for catheter-related bacteremia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Hospitalization in a department of Nice University Hospital
- Expected length of hospitalization ≥ 72 hours
- Diagnosis of catheter-related bacteremia on PICCline or Midline.
- Affiliation with a social security system
- No objection to the study
Who cannot join
- Pregnant or breastfeeding women
- Legal protection measures (patients under guardianship, trusteeship, or judicial protection)
- Inability to remove the catheter
- Doppler ultrasound showing DVT in the upper limb at selection.
- Inability to perform the initial routine Doppler ultrasound
- Withdrawal of the patient's consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de NICE
Nice, CHU de Nice, 06200
Irit TOUITOU, 0492035847, touitou.i@chu-nice.fr
Dylan MAZZOLENI, mazzoleni.d@chu-nice.fr
About this study
The use of long-term peripheral venous catheters inserted in the upper limb (PICC lines and Midlines) has increased markedly over recent years.
Catheter-related bacteremias and venous thromboses are the main complications associated with these catheters. These events may occur independently or simultaneously. In addition, venous thromboses may involve the superficial venous system (SVT) or the deep venous system (DVT).
Read more
Current guidelines define septic thrombophlebitis as the association of a bacteremia and a DVT along the venous course of the catheter. This represents a severe complication of catheter-related bacteremia, leading to a modification in the duration of antibiotic therapy. However, SVTs associated with catheter-related bacteremias along the catheter pathway are not included in the definition of septic thrombophlebitis and are not addressed by specific recommendations.
The objective of this study is therefore to assess the impact of upper-limb SVT on the frequency of unfavorable outcomes in catheter-related bacteremias related to PICC and Midline catheters, in order to determine whether superficial venous thrombosis occurring in the context of a catheter-related bacteremia should be considered a distinct entity not falling under the diagnosis of septic thrombophlebitis (and therefore not requiring a modification of antibiotic treatment duration, in accordance with current guidelines), or whether, conversely, it should be considered equivalent to septic thrombophlebitis, as is the case for deep venous thrombosis.
- Conditions
- Catheter Associated Infection
- Being tested
- Follow-up for catheter-related bacteremia
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up for catheter-related bacteremiaOther
Clinical follow-up and outcomes of patients with catheter-related bacteremia
| Study group | Role | What they receive |
|---|---|---|
| Catheter Associated Infection | Experimental | Not described Receives: Other: Follow-up for catheter-related bacteremia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT)
An unfavorable outcome is defined as a composite endpoint including at least one of the following:
- Relapse of bacteremia documented with the same microorganism and/or
- Extension of superficial venous thrombosis to the deep venous system (deep vein thrombosis and/or pulmonary embolism) and/or
- Infectious complications related to the initial diagnosis of catheter-related bacteremia, including infective endocarditis, deep abscess, septic thrombophlebitis, osteoarticular infection, or any other complication related to CRBSI, and/or
- Septic shock.
Measured: At day 28 after completion of treatment for catheter-related bacteremia
Secondary outcomes (2)
Describe the risk factors associated with the occurrence of deep vein thrombosis.
Comparison of patient parameters and management with the course of catheter-related bacteremia
Measured: At day 28 after completion of treatment for catheter-related bacteremia
Describe the imaging findings and the evolution of catheter-related deep vein thrombosis
Comparison of echo-doppler imaging between inclusion and 14 days after antibiotics treatment
Measured: At day 14 after completion of treatment for catheter-related bacteremia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Feb 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Associated InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388381
- Sponsor's protocol ID
- 25-PP-07
- Acronym
- THROMBI-CATH
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences
- ClinicalTrials.gov ID
- NCT07388381
- Acronym / sponsor ID
- THROMBI-CATH / 25-PP-07
- Conditions
- Catheter Associated Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 5 Feb 2026 (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.
The use of long-term peripheral venous catheters inserted in the upper limb (PICC lines and Midlines) has increased markedly over recent years.
Catheter-related bacteremias and venous thromboses are the main complications associated with these catheters. These events may occur independently or simultaneously. In addition, venous thromboses may involve the superficial venous system (SVT) or the deep venous system (DVT).
Current guidelines define septic thrombophlebitis as the association of a bacteremia and a DVT along the venous course of the catheter. This represents a severe complication of catheter-related bacteremia, leading to a modification in the duration of antibiotic therapy. However, SVTs associated with catheter-related bacteremias along the catheter pathway are not included in the definition of septic thrombophlebitis and are not addressed by specific recommendations.
The objective of this study is therefore to assess the impact of upper-limb SVT on the frequency of unfavorable outcomes in catheter-related bacteremias related to PICC and Midline catheters, in order to determine whether superficial venous thrombosis occurring in the context of a catheter-related bacteremia should be considered a distinct entity not falling under the diagnosis of septic thrombophlebitis (and therefore not requiring a modification of antibiotic treatment duration, in accordance with current guidelines), or whether, conversely, it should be considered equivalent to septic thrombophlebitis, as is the case for deep venous thrombosis.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter Associated Infection | Experimental | Other: Follow-up for catheter-related bacteremia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Hospitalization in a department of Nice University Hospital
- Expected length of hospitalization ≥ 72 hours
- Diagnosis of catheter-related bacteremia on PICCline or Midline.
- Affiliation with a social security system
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Legal protection measures (patients under guardianship, trusteeship, or judicial protection)
- Inability to remove the catheter
- Doppler ultrasound showing DVT in the upper limb at selection.
- Inability to perform the initial routine Doppler ultrasound
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 |
|---|---|---|
| Follow-up for catheter-related bacteremiaClinical follow-up and outcomes of patients with catheter-related bacteremia | Other | Catheter Associated Infection |
Primary outcome
Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT)
Time frame: At day 28 after completion of treatment for catheter-related bacteremia
An unfavorable outcome is defined as a composite endpoint including at least one of the following: * Relapse of bacteremia documented with the same microorganism and/or * Extension of superficial venous thrombosis to the deep venous system (deep vein thrombosis and/or pulmonary embolism) and/or * Infectious complications related to the initial diagnosis of catheter-related bacteremia, including infective endocarditis, deep abscess, septic thrombophlebitis, osteoarticular infection, or any other complication related to CRBSI, and/or * Septic shock.
2 secondary outcomes
Describe the risk factors associated with the occurrence of deep vein thrombosis.
Time frame: At day 28 after completion of treatment for catheter-related bacteremia
Describe the imaging findings and the evolution of catheter-related deep vein thrombosis
Time frame: At day 14 after completion of treatment for catheter-related bacteremia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up for catheter-related bacteremia in people with Catheter Associated Infection, run by Centre Hospitalier Universitaire de Nice 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa DEMONCHY (0492035847, demonchy.e@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT) (time frame: At day 28 after completion of treatment for catheter-related bacteremia). 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 22 Jun 2026.