CClinicalTrials.gg
RecruitingNCT07388381THROMBI-CATHUpdated Jun 22, 2026

Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences

An interventional study of Follow-up for catheter-related bacteremia in Catheter Associated Infection, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Catheter Associated Infection
03

In context

Catheter-Related Infections

107 studies on the registry are indexed under Catheter-Related Infections; 16 are open to participants now.

This study's planned enrollment of 150 is close to the median of 150 across 76 interventional studies indexed under Catheter-Related Infections.

Browse Catheter-Related Infections studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Catheter Associated Infection

    Other: Follow-up for catheter-related bacteremia

Interventions

  • OtherFollow-up for catheter-related bacteremia

    Clinical follow-up and outcomes of patients with catheter-related bacteremia

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At day 28 after completion of treatment for catheter-related bacteremia

Secondary outcomes

  1. 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

    Time frame: At day 28 after completion of treatment for catheter-related bacteremia

  2. 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

    Time frame: At day 14 after completion of treatment for catheter-related bacteremia

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07388381
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Feb 5, 2026
Start date
Feb 9, 2026
Primary completion
Oct 30, 2027 (estimated)
Completion
Oct 30, 2027 (estimated)
Last update
Jun 22, 2026

Study contacts

Elisa DEMONCHY
Contact
demonchy.e@chu-nice.fr
0492035847
Dylan MAZZOLENI
Contact
mazzoleni.d@chu-nice.fr
+33 7 68 25 71 76

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion