Septic ThrombophlebitisTHROMBOSEPNCT05743738
Description of Septic Thrombophlebitis on Central Venous Catheter and Midline
A study testing Doppler ultrasound in people with Septic Thrombophlebitis, run by Centre Hospitalier le Mans at 2 sites in France.
Trial summary
Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Thrombophlebitis
- What is being tested?
- Doppler ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 31 May 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patient hospitalised at the CHM or CHUA, with a central venous device (Implantable chamber, central venous jugular, femoral, subclavian, PICCline, dialysis catheter) or a Midline and having catheter-related bacteremia
- Catheter-related bacteremia according to the following definition (ePOPI): Positive blood cultures within 48 hours of a suspected catheter infection (or its removal) With one of the following criteria: - Before catheter removal: differential time of positivity of central/peripheral blood cultures ≥ 2 hours
- After catheter removal: positive catheter culture ≥ 103 CFU/ml, with the same organism.
- Patient transportable for ultrasound or ultrasound can be performed in the patient's bed
- Patient capable of giving consent, or consent of the trusted person for patients not capable of giving consent at the time of inclusion
- Written consent signed by the participant and the investigator
- Person affiliated to social security
Who cannot join
- Patient with a life expectancy of less than one month
- Contraindication to anticoagulation
- Patient already on curative anticoagulant therapy for any indication
- Minor or adult patient under guardianship or protected or deprived of liberty
- Pregnant, nursing or parturient woman
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
CHU Angers
Angers, 49000
Diama NDIAYE, MD, 02 41 35 33 05, Diama.Ndiaye@chu-angers.fr
Diama NDIAYE, MD
- Recruiting
Centre Hospitalier Le Mans
Le Mans, 72 000
Christelle Jadeau, PD, 02 44 71 07 81, cjadeau@ch-lemans.fr
Lucia Grandiere-Perez, MD, 0 (33) 2 43 43 43 43, lperez@ch-lemans.fr
About this study
Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Despite these advantages, the long-term presence of central venous catheters is associated with thrombotic and infectious risks , including catheter-related bacteremia, which can be complicated by septic thrombophlebitis and endocarditis that can lead to death.
Septic thrombophlebitis is a complication of venous catheter infections, which increases the morbidity. It is defined by the presence of a thrombosis in the vein where the venous catheter is located, associated with a bacteremia. A distinction is made between superficial and deep thrombophlebitis.
Read more
The frequency of septic thrombophlebitis of venous catheters is variable and poorly described in the literature.
When the diagnosis of septic thrombophlebitis is made, it is recommended to extend the duration of antibiotic therapy, to remove the infected catheter and to prescribe anticoagulant treatment. However, there is no recommendation on the duration of anticoagulation for septic thrombophlebitis, whether it is deep or superficial.
Investigator proposes a prospective and descriptive interventional study to describe the ultrasound evolution of thrombus in patients with septic thrombophlebitis on central venous catheter and midline.
- Conditions
- Septic Thrombophlebitis
- Being tested
- Doppler ultrasound
- Keywords
- septic thrombophlebitis, Doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundDiagnostic test
Control venous Doppler ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Presence of thrombosis | Other | Doppler ultrasound D8, D15, D30, D45, D60 and D90 Receives: Diagnostic Test: Doppler ultrasound |
| Absence of thrombosis | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline
the duration is measured by time from the day of diagnosis of septic thrombophlebitis to the day of disappearance of signs of thrombophlebitis on Doppler ultrasound
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start31 May 2023
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ThrombophlebitisStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743738
- Sponsor's protocol ID
- CHM-2020/S10/14
- Acronym
- THROMBOSEP
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Septic Thrombophlebitis on Central Venous Catheter and Midline
- ClinicalTrials.gov ID
- NCT05743738
- Acronym / sponsor ID
- THROMBOSEP / CHM-2020/S10/14
- Conditions
- Septic Thrombophlebitis
- Keywords
- septic thrombophlebitis, Doppler ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Feb 2023 (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.
Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Despite these advantages, the long-term presence of central venous catheters is associated with thrombotic and infectious risks , including catheter-related bacteremia, which can be complicated by septic thrombophlebitis and endocarditis that can lead to death.
Septic thrombophlebitis is a complication of venous catheter infections, which increases the morbidity. It is defined by the presence of a thrombosis in the vein where the venous catheter is located, associated with a bacteremia. A distinction is made between superficial and deep thrombophlebitis.
The frequency of septic thrombophlebitis of venous catheters is variable and poorly described in the literature.
When the diagnosis of septic thrombophlebitis is made, it is recommended to extend the duration of antibiotic therapy, to remove the infected catheter and to prescribe anticoagulant treatment. However, there is no recommendation on the duration of anticoagulation for septic thrombophlebitis, whether it is deep or superficial.
Investigator proposes a prospective and descriptive interventional study to describe the ultrasound evolution of thrombus in patients with septic thrombophlebitis on central venous catheter and midline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presence of thrombosis | Other | Diagnostic Test: Doppler ultrasoundDoppler ultrasound D8, D15, D30, D45, D60 and D90 |
| Absence of thrombosis | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient hospitalised at the CHM or CHUA, with a central venous device (Implantable chamber, central venous jugular, femoral, subclavian, PICCline, dialysis catheter) or a Midline and having catheter-related bacteremia
- Catheter-related bacteremia according to the following definition (ePOPI): Positive blood cultures within 48 hours of a suspected catheter infection (or its removal) With one of the following criteria: - Before catheter removal: differential time of positivity of central/peripheral blood cultures ≥ 2 hours
- After catheter removal: positive catheter culture ≥ 103 CFU/ml, with the same organism.
- Patient transportable for ultrasound or ultrasound can be performed in the patient's bed
- Patient capable of giving consent, or consent of the trusted person for patients not capable of giving consent at the time of inclusion
Key exclusion criteria (5 listed)
- Patient with a life expectancy of less than one month
- Contraindication to anticoagulation
- Patient already on curative anticoagulant therapy for any indication
- Minor or adult patient under guardianship or protected or deprived of liberty
- Pregnant, nursing or parturient woman
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 |
|---|---|---|
| Doppler ultrasoundControl venous Doppler ultrasound | Diagnostic test | Presence of thrombosis |
Primary outcome
Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline
Time frame: Day 90
the duration is measured by time from the day of diagnosis of septic thrombophlebitis to the day of disappearance of signs of thrombophlebitis on Doppler ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler ultrasound in people with Septic Thrombophlebitis, run by Centre Hospitalier le Mans at 2 sites 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (+33244710781, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of duration of ultrasound signs of septic thrombophlebitis on central venous catheter and midline (time frame: Day 90). 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 15 Jun 2023.