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CompletedNCT06036628BREFUpdated Mar 19, 2026

Resistant Bacteria in Children in France

An observational study in Infection Due to Resistant Bacteria, Multi-antibiotic Resistance and Antibiotic Prescription, sponsored by Association Clinique Thérapeutique Infantile du val de Marne. Completed at 1 site in France. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Association Clinique Thérapeutique Infantile du val de Marne · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
306
Ages
Up to 17 Years
Sex
All
01

Study summary

This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria

Read the detailed description

The main of this study is to evaluate the relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation

As this is a surveillance study, the clinical and biological characteristics of the children included will be described.

02

Conditions studied

  • Infection Due to Resistant Bacteria
  • Multi-antibiotic Resistance
  • Antibiotic Prescription
  • Risk Factors
  • Healing
  • Complications
  • Intensive Care Unit
  • Hospital Discharge
  • Outcome, Fatal
03

In context

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

pediatrics patients infected by multi-resistant bacterial, treated by new antibiotics

Inclusion criteria

  • Children under 18 years of age
  • Hospitalized in France in a hospital center working with the ACTIV/GPIP network
  • Treated with one or more of the following antibiotics:

    • Colimycin (Colistimethate sodium)
    • Cefiderocol
    • Aztreonam in combination
    • Ceftolozane-Tazobactam
    • Ceftazidime-avibactam
    • Meropenem/vaborbactam
    • Imipenem/Relebactam
    • Tigecycline
    • Daptomycin
    • Ceftaroline fosamil
    • Tedizolid phosphate
    • Fidaxomicin
    • Ceftobiprole
    • Dalbavancin

In association with a documented infection performed by:

  • Blood culture
  • Normally sterile site

    • Cerebrospinal fluid
    • Pleural fluid
    • Pleura
    • Peritoneum
    • Joint fluid
    • Other
  • Urine sampling if the bacteria was considered responsible for the infection (associated with a leukocyturia ≥10,0000)
  • Respiratory specimens if the bacteria was considered responsible for the infection
  • Sampling on material such as:Intubation probe, Orthopedic, Urological, Central Nervous System (CNS),....

    • Related to colonization with multidrug-resistant bacteria without documentation.

Exclusion criteria

Exclusion Criteria:

  • Refusal of participation by the patient or his/her parent
  • Medical history of mucoviscidosis
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
306 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Relevance of prescribing "new antibiotics" according to patient status

    Type of new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation

    Time frame: 1 year

  2. Relevance of prescribing "new antibiotics"

    how are used new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria

    Time frame: 1 year

Secondary outcomes

  1. Describe Bacterial epidemiology of infections associated with prescription of new antibiotics

    Characteristic of bacteria associated with prescription of new antibiotics

    Time frame: 1 year

  2. Identify Risks factors for multi-resistant bacteria

    Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,

    Time frame: 1 year

  3. Describe Context of drug Prescription

    How antibiotics medical prescriptions are controlled and validated

    Time frame: 1 year

  4. Department involved in medical prescribing

    Number of department involved in medical prescriptions

    Time frame: 1 year

  5. Describe Associated Antibiotherapies type

    Type of drug association prescribed

    Time frame: 1 year

  6. Describe Associated Antibiotherapies

    Number of drug association prescribed

    Time frame: 1 year

  7. Describe patients outcome

    Proportion of patients clinically and bacteriologically recovered

    Time frame: 1 year

07

Study locations

1 site
  • ACTIV
    Créteil, 94000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06036628
Lead sponsor
Association Clinique Thérapeutique Infantile du val de Marne
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Apr 1, 2023
Primary completion
Oct 31, 2025
Completion
Dec 19, 2025
Last update
Mar 19, 2026

Study contacts

Levy Corinne
study director · Association Clinique Thérapeutique Infantile du val de Marne
Cohen Robert
principal investigator · Association Clinique Thérapeutique Infantile du val de Marne

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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