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CompletedNCT04009785PEDIAOBSTUpdated Dec 16, 2025

Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home

An observational study in Anti Infective and Pediatric Population, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 0 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
0 Years to 16 Years
Sex
All
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Study summary

Nowadays, resistance to anti-infectives has become a global public health problem and its increased prevalence threatens human health.

To date, few studies have focused on drug compliance in the paediatric population and it varies according to the pathology This drug adherence in the paediatric population is directly linked to outpatient care by the parents or the child's immediate family. In addition, there are no studies on adherence to antibiotics prescribed at the end of hospitalization in the paediatric population.

In this context, it seems urgent to seek an intervention capable of leading to responsible and appropriate use of antibiotics in order to improve efficiency in the drug management of acute paediatric infections.

This pilot study would characterize pediatric patients and determine the compliance rate in this population.

02

Conditions studied

  • Anti Infective
  • Pediatric Population
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

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

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Who can participate

Ages eligible
0 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients included in the study are patients under 16 years of age (\< 16 years of age) admitted to full hospitalization in the paediatric units

Inclusion criteria

  • The patient is under 16 years of age (\< 16 years of age).
  • The patient is admitted to a full hospitalization in one of the 2 paediatric units of the University Hospital of Nîmes.
  • The patient is discharged with a prescription for anti-infectives to be taken at home, for a maximum of 30 days.
  • The patient and the holder of parental authority are available for a follow-up of 1 month after discharge from hospital.

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rate of patients observing anti-infectives

    Time frame: 2018

Secondary outcomes

  1. Rehospitalization rates / emergency visits related to worsening infection

    Time frame: 2018

Other outcomes

  1. Rate of observing patients who have recovered their anti-infective treatment

    Time frame: 2018

  2. Rate of observing patients who have taken anti-infective treatment as prescribed

    Time frame: 2018

  3. Sociodemographic and clinical characteristics

    Time frame: 2018

  4. Overall success rate in the quiz on understanding anti-infectives

    Time frame: 2018

07

Study locations

1 site
  • Chu Nimes
    Nîmes, 30029, France
08

References and documents

Publications

  • Warembourg M, Lonca N, Filleron A, Tran TA, Knight M, Janes A, Soulairol I, Leguelinel-Blache G. Assessment of anti-infective medication adherence in pediatric outpatients. Eur J Pediatr. 2020 Sep;179(9):1343-1351. doi: 10.1007/s00431-020-03605-8. Epub 2020 Mar 5. PubMed 32140853 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04009785
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jul 5, 2019
Start date
Mar 6, 2018
Primary completion
May 4, 2018
Completion
May 4, 2018
Last update
Dec 16, 2025

Oversight

Data monitoring committee
No
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 Dec 2025. You cannot join it, but the record below documents what was studied.

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