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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07388381
Acronym
THROMBI-CATH
Enrollment
150
Registered
2026-02-05
Start date
2026-02-09
Completion date
2027-10-30
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Associated Infection

Brief 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.

Interventions

OTHERFollow-up for catheter-related bacteremia

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of unfavorable outcomes according to the presence or absence of superficial venous thrombosis (SVT)At day 28 after completion of treatment for catheter-related bacteremiaAn 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.

Secondary

MeasureTime frameDescription
Describe the risk factors associated with the occurrence of deep vein thrombosis.At day 28 after completion of treatment for catheter-related bacteremiaComparison of patient parameters and management with the course of catheter-related bacteremia
Describe the imaging findings and the evolution of catheter-related deep vein thrombosisAt day 14 after completion of treatment for catheter-related bacteremiaComparison of echo-doppler imaging between inclusion and 14 days after antibiotics treatment

Countries

France

Contacts

CONTACTElisa DEMONCHY
demonchy.e@chu-nice.fr0492035847
CONTACTDylan MAZZOLENI
mazzoleni.d@chu-nice.fr+33 7 68 25 71 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026