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Pharmacokinetics, efficacy and safety of polymyxin B combined tigecycline in metallo-beta-lactamase producing carbapenem-resistant Entrobacteriaceae blood stream infection patients: a prospective, multi-centered, open-label trial

Pharmacokinetics, efficacy and safety of polymyxin B combined tigecycline in metallo-beta-lactamase producing carbapenem-resistant Entrobacteriaceae blood stream infection patients: a prospective, multi-centered, open-label trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035119
Enrollment
Unknown
Registered
2020-08-01
Start date
2020-08-31
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

metallo-beta-lactamase producing carbapenem-resistant Entrobacteriaceae blood stream infection

Interventions

polymyxin B +tigecycline:polymyxin B + tigecycline

Sponsors

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with a clinical diagnosis of blood stream infection, and blood culture revealed MBL-CRE or high suspect of MBL-CRE infection; 2. Inpatients aged >= 18; 3. Female at child-bearing age with negative blood HCG test and willing to take contraceptives; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Systemic use of antibiotics susceptive to MBL-CRE more than 48 hours in 72 hours before inclusion; 2. Ccr below 50 mL/min; 3. ALT level above 5-fold high criteria, or TBL level above 3-fold high criteria; 4. Glasgow score <= 8, or expect life less than 1 month; 5. Allergy to polymyxin B or tigecycline; 6. Included in another trial in 3 months, 7. Pregnant or feeding woman; 8. Patient can not follow the study schedual; 9. Patient who's inclusion will affect safety or data quality; 10. History of epilepsy or myasthenia gravis; 11. Patient not able to sampling continuously; 12. Co-use nephrotoxic drug when inclusion or high possible during study period.

Design outcomes

Primary

MeasureTime frame
pharmacokinetic parameters;efficacy;safety;

Countries

China

Contacts

Public ContactYu Yunsong

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

yvys119@163.com+86 15990020502

Outcome results

None listed

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