Drug Interaction Clinical Trial
— PROSITOfficial title:
Development, Validation and Impact of an Automatic Identification of Co-Prescription at Risk of Interactions in the Hospital Information System. The PRoSIT System.
The French Public Health strategy 2018-2022 aims to reduce inappropriate prescriptions, as potentially dangerous for individuals and collectively. The reduction of co-prescriptions at Risk of Drug Interactions (RoDI) could decrease the prevalence of iatrogenic diseases, and increase the persistence of treatments with a growing efficacy of treatments, in particular in elderly populations. A recent study conducted by our team showed that, in out-patient setting, 2.7% of co-prescriptions contains medications at RoDI of high degree of severity (object of a contra-indication or non-recommended). Up today, there is no French experience concerning the identification of RoDI among the prescriptions performed at the end of a hospitalisation. In France, the recent development of hospital data warehouses is a huge opportunity to develop a system that can identify efficiently co-prescriptions at RoDI and provide feedback directly to prescribers in order to reduce their frequency in hospital context. The primary objective of this study is to evaluate the capacity of a system, called PRoSIT system, to automatically identify the RoDI of high level of severity at hospital discharge.
Status | Not yet recruiting |
Enrollment | 5769 |
Est. completion date | February 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - A total of 5 676 hospital discharge prescriptions, defined as the list of medications prescribed at discharge from hospital or after a hospital visit, whether new or renewed, will be selected if they concern: patients aged 65 years or older AND in the cardiology, internal medicine and neurology departments of University Hospital of Bordeaux, University Hospital of Rennes, and Georges Pompidou European Hospital recorded between June 1, 2018 and June 1, 2019. - For the evaluation of the determinants of acceptability and effectiveness of the intervention: a group of 18 hospital practitioners and three hospital pharmacists from the concerned departments of Bordeaux University Hospital will be included. - For phase 3, all hospital discharge prescriptions for patients aged 65 or over hospitalized or seen in consultation in the cardiology, internal medicine and neurology divisions only of the Bordeaux University Hospital will be used to analyse the impact of the feedback. Exclusion Criteria: • Hospital discharge prescriptions not corresponding to inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
France | Hopital Pellegrin | Bordeaux | |
France | Hôpital Européen George Pompidou | Paris | |
France | CHU de Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Synapse bv |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of automatic identification of co-prescription at Risk of Drug Interactions (RoDI) | Thanks to PRoSIT tool and interface development. The PRoSIT tool will identify all the drugs listed in the hospital discharge prescriptions and will automatically search for IMPs, through the thesaurus of interaction of the French Agency of Drug Safety. | 36 months after inclusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04645940 -
Fruquintinib Food Effect and Proton Pump Inhibitor Study
|
Phase 1 | |
Completed |
NCT04540965 -
Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04531072 -
Effect of Atazanavir-ritonavir on the Pharmacokinetics and Toxicity of Lumefantrine
|
Phase 4 | |
Completed |
NCT03385525 -
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
|
Phase 1 | |
Completed |
NCT05680792 -
Pharmacokinetic Interaction Between Nitazoxanide and Atazanavir/Ritonavir in Healthy Volunteers
|
N/A | |
Completed |
NCT05137548 -
A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT05525351 -
The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia
|
||
Terminated |
NCT01980342 -
Pharmacokinetics and Pharmacodynamics of the Etonogestrel Contraceptive Implant When Co-administered With Efavirenz
|
Phase 4 | |
Completed |
NCT04080596 -
DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin
|
Phase 1 | |
Recruiting |
NCT04593680 -
Assessment of Drug-drug Interactions Between Masculinizing Hormone Therapy and Antiretroviral Agents Concomitantly for Pre-exposure Prophylaxis Among Transgender Men
|
N/A | |
Active, not recruiting |
NCT04590417 -
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women
|
N/A | |
Completed |
NCT05633147 -
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
|
Phase 1 | |
Completed |
NCT02391688 -
Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail
|
Phase 1 | |
Completed |
NCT00806299 -
Loperamide Grapefruit Juice Interaction PK Trial
|
Phase 1 | |
Completed |
NCT03336346 -
Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana
|
||
Completed |
NCT04818086 -
Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
|
Phase 1/Phase 2 | |
Completed |
NCT03187015 -
A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects
|
Phase 1 | |
Not yet recruiting |
NCT03920566 -
The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs
|
||
Completed |
NCT03011996 -
To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration
|
Phase 1 | |
Completed |
NCT04902105 -
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite
|
Phase 1 |