Anti InfectivePEDIAOBSTNCT04009785
Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home
An observational study of Anti Infective and Pediatric Population, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Anti Infective, Pediatric Population
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2018to 4 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Anti Infective, Pediatric Population
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients observing anti-infectives
Measured: 2018
Secondary outcomes (1)
Rehospitalization rates / emergency visits related to worsening infection
Measured: 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Mar 2018
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti InfectiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009785
- Sponsor's protocol ID
- Mobilité/2017/GLB
- Other IDs
- 2017-A03114-49
- Acronym
- PEDIAOBST
- Status last verified
- Dec 2025
- First submitted
- 1 Jul 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home
- ClinicalTrials.gov ID
- NCT04009785
- Acronym / sponsor ID
- PEDIAOBST / Mobilité/2017/GLB
- Conditions
- Anti Infective, Pediatric Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 5 Jul 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
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
Rate of patients observing anti-infectives
Time frame: 2018
1 secondary outcome
Rehospitalization rates / emergency visits related to worsening infection
Time frame: 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publication: PubMed 32140853Warembourg 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti Infective and Pediatric Population, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients observing anti-infectives (time frame: 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04009785, which also lists 1 linked publication.
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 16 Dec 2025.