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Trial record 1 of 1 for:    NCT04222257
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Short-course Antibiotic Treatment in Gram-positive Cocci Infective Endocarditis (SATIE)

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ClinicalTrials.gov Identifier: NCT04222257
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Carmen Olmos Blanco, Hospital San Carlos, Madrid

Brief Summary:

Background: it is well known that most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which are the first days after diagnosis. Subsequently, the vast majority of patients who overcome this acute phase has a favourable evolution, and usually stay in the hospital for a long time only to complete antibiotic therapy.

In stable patients with adequate response to antibiotic treatment, without signs of persistent infection or metastatic foci such as spondylodiscitis, it is likely that a shorter antibiotic regimen would be an efficient and safe alternative, as has already been confirmed in patients with IE on tricuspid valves caused by a microorganism considered virulent such as S. aureus. This attractive alternative would improve patients' quality of life, save costs, and decrease the risk of complications related to the adverse effects of prolonged antibiotic treatment.

Objectives: to compare the incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion between patients with IE caused by gram-positive cocci receiving a short-course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy (4-6 weeks).

Methodology: multicenter, prospective, randomized, controlled open-label, phase IV clinical trial. 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 antibiotic therapy, according to ESC guidelines recommendations, for 4 to 6 weeks. Experimental group: short-course antibiotic therapy for 2 weeks. The prevalence of previously known risk factors for adverse events will be compared between the two groups to confirm that randomization have worked properly. The incidence of the 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.


Condition or disease Intervention/treatment Phase
Endocarditis, Bacterial Drug: Antibiotics Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-course Antibiotic Regimen Compared to Conventional Antibiotic Treatment for Gram-positive Cocci Infective Endocarditis: Randomized Clinical Trial
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short course
Patients allocated to this group will receive a short course of antibiotic therapy for 2 weeks.
Drug: Antibiotics
Patients allocated to this group will receive a short course of antibiotic therapy for 2 weeks.

Active Comparator: Standard course
Those patients allocated to continue with standard parenteral treatment will maintain the same antibiotic treatment for 4 to 6 weeks.
Drug: Antibiotics
Patients allocated to continue with standard parenteral treatment will maintain the same antibiotic treatment for 4 to 6 weeks.




Primary Outcome Measures :
  1. Composite endopoint [ Time Frame: 6 months ]
    To compare the incidence of the composite endpoint that includes all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion, between patients with IE caused by gram-positive cocci receiving a short course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy for 4-6 weeks.


Secondary Outcome Measures :
  1. Perceived quality of life: SF-12 [ Time Frame: 4 weeks ]
    Determination of quality of life (SF-12)

  2. Functional performance [ Time Frame: 4 weeks ]
    Determination of functional performance according to the short performance physical battery test (SPPB)

  3. Clinical complications [ Time Frame: 6 months ]
    Clinical complications related to hospital stay (nosocomial infections, intravascular catheter-related infections)

  4. Total hospital length of stay [ Time Frame: 6 months ]
    Total hospital length of stay in the next 6 months after the inclusion in the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Definite IE, according to modified ESC 2015 criteria, caused by gram-positive cocci (staphylococci, streptococci and enterococci), including native, prosthetic valve IE and cardiac device-related IE.
  • 18 years old or older.
  • Patients treated for at least 10 days of appropriate parenteral antibiotic therapy overall (according to guidelines and microbiology sensitivity testing), and at least 7 days of parenteral antibiotic therapy after valve surgery when indicated.
  • Absence of fever, microbiological or analytical findings suggesting persistent infection at randomization.
  • Absence of locally uncontrolled infection signs (abscess, pseudoaneurysm, fistula, enlarging vegetation) at randomization, confirmed by recent transesophageal echocardiography (performed within 48 h of randomization).
  • Women of childbearing potential who will agree to the use of effective contraceptive methods while on antibiotic treatment.

Exclusion Criteria:

  • Patients who have received appropriate parenteral antibiotic therapy for infective endocarditis for more than 12 days.
  • Patients not suitable to be discharged after 10 days of conventional treatment, due to clinical reasons (sequels of stroke that prevent discharge, progressive renal failure, hepatic failure).
  • Patients receiving chemotherapy or immunosuppressive therapy.
  • Pregnant or breastfeeding women.
  • Need of prolonged antibiotic therapy due to spondylodiscitis or other septic complication.
  • Absence of patient's ability or commitment to continue follow-up after being discharged from hospital.
  • Inability to give informed consent to participation.
  • Cognitive impairment or lack of language skills needed to complete the questionnaires.
  • Patients who meet urgent cardiac surgery ESC criteria but are considered inoperable due to high surgical risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222257


Contacts
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Contact: Carmen Olmos Blanco, MD +0034-913303149 carmen.olmosblanco@gmail.com

Locations
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Spain
Cardiovascular Institute. Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Carmen Olmos Blanco    +0034-913303149      
Sponsors and Collaborators
Carmen Olmos Blanco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carmen Olmos Blanco, Principal investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT04222257    
Other Study ID Numbers: SATIE
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmen Olmos Blanco, Hospital San Carlos, Madrid:
Infective endocarditis
short-course
antibiotic therapy
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents