Skip to content

The study of effectiveness and safety evaluation of high dose datoromycin in ICU patients

The study of effectiveness and safety evaluation of high dose datoromycin in ICU patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041991
Enrollment
Unknown
Registered
2021-01-11
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

patients with suspected or confirmed severe infection caused by gram-positive cocci

Interventions

Conventional dose group:daptomycin 6 mg/kg Q24h
High dose group:daptomycin 10 mg/kg Q24h

Sponsors

The Second Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Confirmed patients with severe infection caused gram positive coccus: Methicillin-resistant Staphylococcus aureus, Methicillin-resistant Staphylococcus epidermidis, Vancomycin-resistant Enterococcus bloodstream infections; Skin and soft tissue infections, bone and joint infections, infective endocarditis, neutropenia with fever, intracranial infections; 2.Suspected patients with severe infection caused by gram positive coccus:bloodstream infection, skin and soft tissue infection, bone and joint infection, infective endocarditis, neutropenia with fever, intracranial infection; If the broad-spectrum antibiotic treatment fails, Gram-positive coccal infection is considered; 3.Aged >= 18 years; 4.Informed consent is signed.

Exclusion criteria

Exclusion criteria: 1. Gram-positive staphylococcus aureus pneumonia; 2. Pregnancy or lactation; 3. Has used daptomycine before inclusion; 4. Allergy to daptomycine; 5. Included in other clinical studies; 6. Quit during the study; 7. Creatinine clearance 30 ml/min or less, or the use of peritoneal dialysis, or intermittent hemodialysis.

Design outcomes

Primary

MeasureTime frame
Percentage of successful clinical treatment;The incidence of acute adverse events;Plasma concentration of datoramycin;

Secondary

MeasureTime frame
Early clinical response;responses to microorganisms;Length of ICU stay;Minimum Inhibitory Concentration (MIC) of Datoromycin;ABCB1 mononucleic acid variants that affect datomycin metabolism;

Countries

China

Contacts

Public ContactHongliang Wang

The Second Affiliated Hospital of Harbin Medical University

icuwanghongliang@163.com+86 15045377888

Outcome results

None listed

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