NCT04009785

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

July 1, 2019

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of patients observing anti-infectives

    2018

Secondary Outcomes (1)

  • Rehospitalization rates / emergency visits related to worsening infection

    2018

Other Outcomes (4)

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

    2018

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

    2018

  • Sociodemographic and clinical characteristics

    2018

  • +1 more other outcomes

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

March 6, 2018

Primary Completion

May 4, 2018

Study Completion

May 4, 2018

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations