Bone and Joint InfectionEFIRADNCT05248490
Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home
A study testing pharmaceutical interview in people with Bone and Joint Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- pharmaceutical interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2022to 14 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > or =18 years;
- Informed consent signed;
- French-speaking and reading;
- Affiliated to a social insurance;
- Benefiting from medical and surgical care for an osteoarticular infection;
- Treated with an oral antibiotic therapy on discharge from hospital.
- Indication of the antibiotic therapy osteoarticular infection;
- Return home immediately after discharge.
Who cannot join
- Refusal to participate
- Protected adult patient, under guardianship or curatorship.
- Minor patient
- Patient benefiting from an AME.
- Pregnant or breastfeeding woman.
- Non-French speaking patient.
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- Patient unable to understand the course of the study.
- Patient with a documented history of cognitive or psychiatric disorders.
- Patient treated with oral antibiotic therapy for an indication other than osteoarticular infection.
- Patient treated with parenteral antibiotic therapy.
- Discharge: Institution (EHPAD), rehabilitation or other health establishment.
- Patient systematically using one of the symptomatic treatments proposed in the discharge prescription before hospitalization.
Trial locations and contacts
1 site in 1 country.
France1 site
Pharmacy of Ambroise-Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.
- Conditions
- Bone and Joint Infection
- Being tested
- pharmaceutical interview
- Keywords
- osteo articular infection, adverse event, antibiotic treatment, pharmaceutical interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical interviewOther
Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Patients with pharmaceutical interview | Experimental | Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization. Receives: Other: pharmaceutical interview |
| Patients without pharmaceutical interview | No intervention | Control group without interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects self-management measurement
Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree.
Proportion of patients with an optimal or non-optimal self-management.
Measured: at day 7
Adverse effects self-management measurement
Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree.
Proportion of patients with an optimal or non-optimal self-management.
Measured: at day 14
Secondary outcomes (1)
Patient knowledge assessment
Questionnaire, 12 points:
- proportion of patients reaching a score upper than 10
- proportion of patients reaching a score between 6 and 9
- proportion of patients reaching a score lower than 6
Measured: at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start22 Mar 2022
- Primary completion5 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Tritz, PharmD, Principal investigator, Pharmacy of Ambroise-Paré hospital, APHPChristophe Menigaux, MD, Study chair, Orthopedic surgery department, Ambroise Paré hospital, APHPNathalie Dournon, MD, Study chair, Infectiology mobile team, Ambroise Paré hospital, APHPJessica Berdougo Berdougo, PharmD, Study chair, Pitié-Salepetrière hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248490
- Sponsor's protocol ID
- APHP211422
- Other IDs
- 2021-A02433-38
- Acronym
- EFIRAD
- Status last verified
- Nov 2024
- First submitted
- 21 Jan 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home
- ClinicalTrials.gov ID
- NCT05248490
- Acronym / sponsor ID
- EFIRAD / APHP211422
- Conditions
- Bone and Joint Infection
- Keywords
- osteo articular infection, adverse event, antibiotic treatment, pharmaceutical interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 21 Feb 2022 (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.
The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pharmaceutical interview | Experimental | Other: pharmaceutical interviewPharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization. |
| Patients without pharmaceutical interview | No intervention | –Control group without interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient > or =18 years;
- Informed consent signed;
- French-speaking and reading;
- Affiliated to a social insurance;
- Benefiting from medical and surgical care for an osteoarticular infection;
Key exclusion criteria (12 listed)
- Refusal to participate
- Protected adult patient, under guardianship or curatorship.
- Minor patient
- Patient benefiting from an AME.
- Pregnant or breastfeeding woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical interviewPharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization | Other | Patients with pharmaceutical interview |
Primary outcome
Adverse effects self-management measurement
Time frame: at day 7
Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree. Proportion of patients with an optimal or non-optimal self-management.
Adverse effects self-management measurement
Time frame: at day 14
Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree. Proportion of patients with an optimal or non-optimal self-management.
1 secondary outcome
Patient knowledge assessment
Time frame: at day 7
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 4 Dec 2024.
- 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. This study is not recruiting at the moment.
Thomas Tritz, PharmD principal investigator
Pharmacy of Ambroise-Paré hospital, APHP
Christophe Menigaux, MD study chair
Orthopedic surgery department, Ambroise Paré hospital, APHP
Nathalie Dournon, MD study chair
Infectiology mobile team, Ambroise Paré hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical interview in people with Bone and Joint Infection, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 12 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 4 Dec 2024. 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?
Adverse effects self-management measurement (time frame: at day 7). The study lists 2 primary outcomes in all. 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 4 Dec 2024.