Tonsillitis AcuteObsATBGignaUrgNCT07711756
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center
An observational study of Tonsillitis Acute and Pneumonia - Bacterial, run by University Hospital, Montpellier.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Tonsillitis Acute, Pneumonia - Bacterial, Otitis Media Acute
- How many people
- 191 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged 3 months to 16 years
- Receiving an outpatient oral antibiotic prescription
- Diagnosed with an acute bacterial infection
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Tonsillitis Acute, Pneumonia - Bacterial, Otitis Media Acute, Cystitis Acute, Sinusitis Bacterial, Pneumonia Atypical
- Keywords
- compliance - antibiotic - pediatric
- Medical subject headings
- Pneumonia, Bacterial, Otitis Media, Pneumonia, Mycoplasma, Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who adhered to the antibiotic prescription provided by the general practitioner (GP) or the emergency physician (University Hospital)
Treatment adherence was considered satisfactory when at least 80% of the prescribed antibiotic course was taken
Measured: The study period extended from the initial consultation (antibiotic prescription) to 21 days after the prescription, depending on the prescribed treatment duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillitis AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric E JEZIORSKI, Professor of Medicine at Montp, Study director, Pediatric Emergency Department, Montpellier University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711756
- Sponsor's protocol ID
- RECHMPL25_0564
- Acronym
- ObsATBGignaUrg
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT07711756
- Acronym / sponsor ID
- ObsATBGignaUrg / RECHMPL25_0564
- Conditions
- Tonsillitis Acute, Pneumonia - Bacterial, Otitis Media Acute, Cystitis Acute, Sinusitis Bacterial, Pneumonia Atypical
- Keywords
- compliance - antibiotic - pediatric
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children aged 3 months to 16 years
- Receiving an outpatient oral antibiotic prescription
- Diagnosed with an acute bacterial infection
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric E JEZIORSKI, Professor of Medicine at Montp study director
Pediatric Emergency Department, Montpellier University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillitis Acute and Pneumonia - Bacterial, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric E JEZIORSKI, Professor of Medicine (+33627383451, e-jeziorski@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.