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Prospective, randomized, noninferiority, open-label, single-center study of continuous intravenous therapy and intravenous oral antibiotics in the treatment of infective endocarditis

Prospective, randomized, noninferiority, open-label, single-center study of continuous intravenous therapy and intravenous oral antibiotics in the treatment of infective endocarditis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034811
Enrollment
Unknown
Registered
2020-07-20
Start date
2020-07-07
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective endocarditis

Interventions

Oral antibiotics:After his condition stabilized, he was discharged from hospital and treated with oral antibiotics
Continuous intravenous:Continuous intravenous therapy

Sponsors

Xiangya Hospital of Centre-south University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Endocarditis based on improved Duke criteria 1. Aged >= 18 years; 2. Generally >= 10 days of appropriate parenteral antibiotic therapy and at least 1 week of appropriate parenteral therapy after valve surgery; 3. Stable condition: body temperature below 38.0 degrees C & GT > 2 days; 4. C-reactive protein decreased to less than 25% of peak value during antibiotic treatment or & LT < 20 mg/L, WBC count & LT < 15 x 10^9 / L; 5. Echocardiography showed no signs of abscess formation; 6. Transthoracic and transesophageal echocardiography were performed within 48 hours prior to random assignment.

Exclusion criteria

Exclusion criteria: 1. Body mass index > 40; 2. With other site infection, intravenous antibiotics are required; 3. Failure to knowingly consent to participate; 4. Suspected reduction in oral absorption due to abdominal disease; 5. Low compliance.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of bacteremia;All cause mortality;Incidence of unplanned cardiac surgery;incidence of thromboembolic events;

Secondary

MeasureTime frame
Treatment cost during hospitalization and follow-up;

Countries

China

Contacts

Public ContactLuo Fanyan

Xiangya Hospital of Centre-South University

drlfy@csu.edu.cn+86 13973129106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026