Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences (THROMBI-CATH)

January 30, 2026 updated by: Centre Hospitalier Universitaire de Nice

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Catheter Associated Infection
Other: Follow-up for catheter-related bacteremia
Clinical follow-up and outcomes of patients with catheter-related bacteremia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At day 28 after completion of treatment for catheter-related bacteremia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Comparison of echo-doppler imaging between inclusion and 14 days after antibiotics treatment
At day 14 after completion of treatment for catheter-related bacteremia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-PP-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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