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An open-label randomized controlled trial of ampicillin/cloxacillin and ceftriaxone for empirical treatment of infective endocarditis

An open-label randomized controlled trial of ampicillin/cloxacillin and ceftriaxone for empirical treatment of infective endocarditis - Comparative trial of ampicillin/cloxacillin with ceftriaxone for empirical treatment of infective endocarditis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032006
Enrollment
30
Registered
2018-03-31
Start date
2018-04-02
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Infective endocarditis

Interventions

Intervention: Ampicillin/cloxacillin 4 g q4h div maximum for 6 weeks + gentamicin 3 mg/kg q24h div maximum for 2 weeks Control: Ceftriaxone 2 g q24h div maximum for 6 weeks + gentamicin 3 mg/kg q24

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with confirmed or suspected diagnosis of infective endocarditis based on the modified Duke's criteria, who need to start empirical treatment waiting for the result of blood cultures.

Exclusion criteria

Exclusion criteria: Causative microorganism already confirmed, history of allergy or contraindication of penicillin, cepharosporins and aminoglycosides, history of prosthetic valve replacement within 1 year, eGFR less than 50 mL/min, WBC less than 1,000/microL, when physicians in charge chose another treatment regimens

Design outcomes

Primary

MeasureTime frame
Outcome of infective endocarditis at the end of antimicrobial treatment

Secondary

MeasureTime frame
Days for defervescence less than 37 degrees Celsius, days of hospitalization, outcome at discharge, necessity of surgery during hospitalization, outcome of infective endocarditis 3 months after the end of antimicrobial treatment Adverse events on skin, blood, liver and kidney

Countries

Japan

Contacts

Public ContactYuki Uehara

Juntendo University Faculty of Medicine Department of General Medicine

yuuehara@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026