Trial · NCT02701595
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment failure | up to 6 months after the end of antibiotic treatment | Failure is a composite outcome defined by death from all causes and/or symptomatic embolic events and/or unplanned valvular surgery and/or a microbiological relapse (with the primary pathogen). |
| Secondary | Death from all-cause | up to 6 months after the end of antibiotic treatment | death from all-causes |
| Secondary | number of symptomatic embolic events | up to 6 months after the end of antibiotic treatment | secondary osteo-articular, splenic or brain localization |
| Secondary | unplanned valvular surgery | up to 6 months after the end of antibiotic treatment | unplanned valvular surgery |
| Secondary | relapse of positive blood cultures | up to 6 months after the end of antibiotic treatment | relapse of positive blood cultures with the primary pathogen |
| Secondary | microbiological relapse with a different pathogen from the primary pathogen | up to 6 months after the end of antibiotic treatment] | Relapse of positive blood cultures with a different pathogen within 3 months after the end of antibiotic therapy |
| Secondary | Echocardiography | up to 6 months after the end of antibiotic treatment | An apparition, an increase or decrease of the following items: vegetation, abscess, perforation, fistula, dehiscence of a prosthetic valve, will be searched at each ultrasound examination at : the end of antibiotic treatment, at 3 months and 6 months after the end of antibiotic treatment |
| Secondary | Catheter related adverse events | up to 6 months after the end of antibiotic treatment | Catheter-related AE: infectious (e.g. catheter-related bacteraemia) or non-infectious catheter-related complications (e.g. extravasation) |
| Secondary | other healthcare-acquired infections | up to 6 months after the end of antibiotic treatment | other healthcare-acquired infections, including urinary tract infections, pneumonia, surgical site infection, Clostridium difficile infections |
| Secondary | Number of participants with an antibiotic modification | up to the end of antibiotic treatment | All change regarding antibiotic treatment administered will be recorded (drug, dose or duration) |
| Secondary | Quality of life | up to 6 months after the end of antibiotic treatment | An assessment of patient's quality of life will be done at the end of antibiotic treatment, at 3 months and 6 months after the end of antibiotic treatment, using the EuroQol Five Dimensions (EQ5D3L) |
| Secondary | numer of participants with a switch back from oral to IV antibiotic treatment | up to the end of antibiotic treatment | For experimental group only . An assessment of the need for a return to parenteral antibiotic in the experimental group. |
| Secondary | Compliance with oral antibiotic treatment | up to 4 weeks after randomisation | For experimental group only. The assessment of compliance with oral antibiotic treatment will be carried out at each visit during the treatment period though a "patient book" which will permit to note take/omissions of treatment; and though the return of the treatments to the pharmacy of the investigational site. Calculation of the duration and cumulative dose of antibiotic treatment actually received will be performed, and compared to the regimen prescribed. |
| Secondary | Cost per patient | up to 6 months after the end of antibiotic treatment | Analysis using data from three centers (Tours, Rennes, Nancy) to compare both strategy (oral switch vs. pan-IV) for the cost per patient |
| Secondary | Budget impact analysis (BIA) | up to 6 months after the end of antibiotic treatment | With data from three centers (Tours, Nancy, Rennes). With data from three centers (Tours, Nancy, Rennes). Allow to estimate the financial consequences of the adoption and diffusion of a new health intervention (the oral strategy). BIA must be calculated on a yearly basis. |
| Secondary | Utility score and incremental cost-utility ratio (ICUR) | up to 6 months after the end of antibiotic treatment | With data from all centers. An assessment of the health related quality of life of the patient will be carried out using a simple generic questionnaire, the EuroQol Five Dimensions (EQ5D3L), recommended by the Washington Panel on Cost Effectiveness (utility) in Health and Medicine, with a cardinal scale and validated French version (http:// www.euroqol.org)Quality of life will be assessed 4 times: at baseline, at the end of antibiotic treatment, at 3 months after end of antibiotic treatment and at the final visit |
| Secondary | Length of hospital stay | up to 6 months after the end of antibiotic treatment | With data from all centers. Length of hospital stay will be calculated as duration between day of start of hospitalization and day of discharge (distinguishing rehabilitation care unit). In case a patient dies during hospitalization, death will be considered as a competing event to discharge |
| Secondary | Residual concentration of antibiotics | 7 days | Pharmacokinetic analysis for the experimental group only: residual concentrations of levofloxacin and rifampicin, or amoxicillin, after 7 days of oral treatment (i.e. at visit 2). |
| Secondary | Biological collection for further analysis on endocarditis | up to 6 months after the end of antibiotic treatment | A biological collection will be constituted in order to perform further biological and genetic analysis of endocarditis (i.e. inflammatory markers of efficacy and genetic markers that predispose to endocarditis). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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