Trial · NCT02701608
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 3 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-cause |
| 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 | number 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. |
| 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.
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