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NCT Number: NCT07388381

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up for catheter-related bacteremia

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Comparison of patient parameters and management with the course of catheter-related bacteremia

  2. 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

    Comparison of echo-doppler imaging between inclusion and 14 days after antibiotics treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Dylan MAZZOLENI

CONTACT

[email protected]

+33 7 68 25 71 76

Elisa DEMONCHY

CONTACT

[email protected]

0492035847

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: THROMBI-CATH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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