NCT05793801

Brief Summary

Peripherally Inserted Central Catheters have been widely used for many years for the administration of chemotherapy to patients with cancer. However, its use entails significant infectious complications and high risks of death.The hypothesis is that increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
16mo left

Started Jun 2023

Typical duration for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2023Sep 2027

First Submitted

Initial submission to the registry

February 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 14, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

February 23, 2023

Last Update Submit

April 11, 2025

Conditions

Leukemia

Keywords

LeukemiaCathetersDressings

Outcome Measures

Primary Outcomes (39)

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 1+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 9+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 17+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 25+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 32+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 39+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 46+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 53+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in controls

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 60+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 1+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 3+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 5+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 7+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 9+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 11+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 13+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 15+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 17+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 19+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 21+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 23+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 25+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 27+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 29+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 31+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 33+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 35+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 37+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 39+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 41+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 43+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 45+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 47+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 49+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 51+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 53+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 55+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 57+48 hours

  • Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group

    Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

    Day 59+48 hours

Secondary Outcomes (44)

  • Pain or discomfort generated by PICCline dressing changes in controls

    Day 1

  • Pain or discomfort generated by PICCline dressing changes in controls

    Day 9

  • Pain or discomfort generated by PICCline dressing changes in controls

    Day 17

  • Pain or discomfort generated by PICCline dressing changes in controls

    Day 25

  • Pain or discomfort generated by PICCline dressing changes in controls

    Day 32

  • +39 more secondary outcomes

Other Outcomes (24)

  • Age of patients in the control group

    At the inclusion visit (- 48 hours to Day 0)

  • Age of patients in the experimental group

    At the inclusion visit (- 48 hours to Day 0)

  • Body Mass Index of patients in the control group

    At the inclusion visit (- 48 hours to Day 0)

  • +21 more other outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients receiving normal management with dressings changed once a week according to the SF2H recommendations.

Other: Dressing change

Experimental group

EXPERIMENTAL

Patients whose dressings are changed every other day.

Other: Dressing change

Interventions

Dressing changeOTHER

The patient circuit corresponds to that of usual care. Not part of usual patient management: * The rhythm of PICCline dressing changes, which differed between the two groups. * The collection of pain on a visual analog scale at each dressing change.

Control groupExperimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a diagnosis of acute myeloblastic leukemia.
  • Patient going on intensive induction chemotherapy (causing a "high risk" situation of severe infection defined as profound neutropenia ( Polymorphonuclear neutrophil count \<500/mm3) and lasting (\>7 days).
  • Patients who have had a PICCline placed within the last 24 hours or who require a PICCline placement as part of their hospitalization under optimal hygiene and asepsis conditions.
  • Patient housed in a protected environment (flow chamber or Plasmair®).
  • Patient who has given free and informed consent.
  • Patient affiliated or beneficiary of a health insurance plan.
  • Adult patient (≥18 years old).

You may not qualify if:

  • Patient with PICCline placed during a previous hospitalization.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier Hôpital St-Eloi

Montpellier, 34090, France

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Julie LASSALLE, Mme.

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Éric JOURDAN, Dr.

CONTACT

+334.66.68.32.34Eric.jourdan@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236drc@chu-nimes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective two-center randomized open-label controlled pilot study in two parallel groups according to PICCline dressing repair: (i) Control group (every 8 days, see SF2H recommendations), (ii) Experimental group (every 2 days).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 31, 2023

Study Start

June 6, 2023

Primary Completion (Estimated)

June 6, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 14, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)