- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07711756
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center (ObsATBGignaUrg)
July 13, 2026 updated by: University Hospital, Montpellier
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: The Gignac Primary Care Medical Center Versus the Pediatric Emergency Department of Montpellier University Hospital (CHU Montpellier).
This study was initiated because of the limited litterature available on this topic.
The objective was to compare adherence to antibiotic therapy among a pediatric population treated in two healthcare settings in France: the Gignac Health Center, a primary care facility, and the Pediatric Emergency Department of Montpellier University Hospital.
This observational study assessed treatment adherence through a telephone questionnaire administered to parents after the theorical end of the treatment.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
191
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric E JEZIORSKI, Professor of Medicine
- Phone Number: +33627383451
- Email: e-jeziorski@chu-montpellier.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pediatric patients presenting to the Gignac Primary Care Health Center or the Pediatric Emergency Department of Montpellier University Hospital with a suspected bacterial infection and considered eligible for an outpatient oral antibiotic prescription.
Description
Inclusion Criteria:
- Children aged 3 months to 16 years
- Receiving an outpatient oral antibiotic prescription
- Diagnosed with an acute bacterial infection
Exclusion Criteria:
- Unemancipated minors presenting without a parent or legal guardian.
- Participation in another clinical research study with an ongoing exclusion period
- Refusal to participate after the reflection period
- Parents unable to understand the study information (e.g., language barrier or cognitive impairment)
- Not affiliated with, or not a beneficiary of, a national health insurance scheme
- Pregnant or breastfeeding female participants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Pediatric patients prescribed antibiotic for acute bacterial infection at the Gignac Health center
Pediatric patients aged 3 months to 16 years presenting with an acute bacterial infection and prescribed an outpatient antibiotic treatment were eligible for inclusion.
Parents were contacted by telephone between 15 and 21 days after the antibiotic prescription to assess treatment adherence.
|
|
Children prescribed antibiotic for acute bacterial infection at pediatric emergency of Montpellier
Pediatric patients aged 3 months to 16 years presenting with an acute bacterial infection at pediatric emergency department Montpellier University Hospital and prescribed an outpatient antibiotic treatment were eligible for inclusion.
Parents were contacted by telephone between 15 and 21 days after the antibiotic prescription to assess treatment adherence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients who adhered to the antibiotic prescription provided by the general practitioner (GP) or the emergency physician (University Hospital)
Time Frame: The study period extended from the initial consultation (antibiotic prescription) to 21 days after the prescription, depending on the prescribed treatment duration.
|
Treatment adherence was considered satisfactory when at least 80% of the prescribed antibiotic course was taken
|
The study period extended from the initial consultation (antibiotic prescription) to 21 days after the prescription, depending on the prescribed treatment duration.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eric E JEZIORSKI, Professor of Medicine at Montp, Pediatric Emergency Department, Montpellier University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
July 13, 2026
First Submitted That Met QC Criteria
July 13, 2026
First Posted (Actual)
July 17, 2026
Study Record Updates
Last Update Posted (Actual)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Skin Diseases
- Pneumonia
- Otorhinolaryngologic Diseases
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Negative Bacterial Infections
- Skin Diseases, Bacterial
- Skin Diseases, Infectious
- Ear Diseases
- Otitis
- Streptococcal Infections
- Mycoplasmatales Infections
- Staphylococcal Skin Infections
- Staphylococcal Infections
- Skin and Connective Tissue Diseases
- Mycoplasma Infections
- Pneumonia, Bacterial
- Otitis Media
- Pneumonia, Mycoplasma
- Impetigo
Other Study ID Numbers
- RECHMPL25_0564
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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