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Clinical Trials/EUCTR2019-003358-10-ES
EUCTR2019-003358-10-ES
Active, not recruiting
Phase 1

Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial

Carmen Olmos Blanco0 sites298 target enrollmentNovember 11, 2019
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Conditionsinfective endocarditisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsBENZETACIL 2.400.000CEFTRIAXONA FRESENIUS KABI 2 g POLVO PARA SOLUCIÓN PARA PERFUSIÓN EFGGENTAMICINA BRAUN 3 mg/ml SOLUCION PARA PERFUSION INTRAVENOSA

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
infective endocarditis
Sponsor
Carmen Olmos Blanco
Enrollment
298
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 11, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Carmen Olmos Blanco

Eligibility 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.
  • •I8 years old or older.
  • •Absence of fever, microbiological or analytical findings suggesting persistent infection after 24h of 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).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 90
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 204

Exclusion Criteria

  • •Patients who recived more than 12 days of target antibiotic treatament to infective endocarditis
  • •Patients not suitable to be discharged after randomization, due to clinical reasons (sequels of stroke that prevent discharge, progressive renal failure, hepatic failure).
  • •Patients with immunosuppressive therapy or chemotherapy
  • •Pregnant and breastfeeding women.
  • •Need of prolonged antibiotic therapy due to spondylodiscitis.
  • •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 Spanish unknowledge
  • •Patients candidate to cardiac surgery considered unoperable due to high surgical risk.

Outcomes

Primary Outcomes

Not specified

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