دورية أكاديمية
Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE)
| العنوان: | Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE) |
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| المؤلفون: | Olmos, C., Vilacosta, I., López, J., Sáez, C., Anguita, M., García-Granja, P. E., Sarriá, C., Silva, J., Álvarez Álvarez, Belén, Martínez Monzonís, Maria Amparo, Castillo, J. C., Seijas, J., López-Picado, A., Peral, V., Maroto, L., San Román, J. A. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Gram-Positive Cocci, Adult, Endocarditis, Middle Aged, Adolescent, Follow-Up Studies, Anti-Bacterial Agents, Gram-Positive Bacterial Infections, Clinical Protocols, Humans, Treatment Outcome, Young Adult, Time Factors, Prospective Studies, Aged, resultado del tratamiento, infecciones por bacterias grampositivas, estudios de seguimiento, estudios prospectivos, mediana edad, adulto, antibacterianos, anciano, protocolos clínicos, adulto joven, humanos, factores de tiempo, cocos grampositivos, adolescente, CHUS |
| الوصف: | BACKGROUND: Most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which represents the first days after diagnosis. The majority of patients overcoming the acute phase has a favorable outcome, yet they remain hospitalized for a long period of time mainly to complete antibiotic therapy. The major hypothesis of this trial is that in patients with clinically stable IE and adequate response to antibiotic treatment, without signs of persistent infection, periannular complications or metastatic foci, a shorter antibiotic time period would be as efficient and safe as the classic 4 to 6 weeks antibiotic regimen. METHODS: Multicenter, prospective, randomized, controlled open-label, phase IV clinical trial with a non-inferiority design to evaluate the efficacy of a short course (2 weeks) of parenteral antibiotic therapy compared with conventional antibiotic therapy (4-6 weeks). SAMPLE: patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients. INTERVENTION: Control group: standard duration antibiotic therapy, (4 to 6 weeks) according to ESC guidelines recommendations. Experimental group: short-course antibiotic therapy for 2 weeks. The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared. CONCLUSIONS: SATIE will investigate whether a two weeks short-course of intravenous antibiotics in patients with IE caused by gram-positive cocci, without signs of persistent infection, is not inferior in safety and efficacy to conventional antibiotic treatment (4-6 weeks). TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04222257 (January 7, 2020). EudraCT ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| تدمد: | 1471-2334 |
| العلاقة: | https://www.ncbi.nlm.nih.gov/pubmed/32546269Test; http://hdl.handle.net/20.500.11940/16542Test; 39265 |
| DOI: | 10.1186/s12879-020-05132-1 |
| الإتاحة: | https://doi.org/20.500.11940/16542Test https://doi.org/10.1186/s12879-020-05132-1Test https://hdl.handle.net/20.500.11940/16542Test https://www.ncbi.nlm.nih.gov/pubmed/32546269Test |
| حقوق: | Atribución 4.0 Internacional ; http://creativecommons.org/licenses/by/4.0Test/ ; openAccess |
| رقم الانضمام: | edsbas.3FC9306C |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 14712334 |
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| DOI: | 10.1186/s12879-020-05132-1 |