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Population pharmacokinetics of polymyxin B in patients infected by carbapenem resistant gram negative bacteria

Population pharmacokinetics of polymyxin B in patients infected by carbapenem resistant gram negative bacteria

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056667
Enrollment
Unknown
Registered
2022-02-10
Start date
2022-02-21
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Carbapenem-resistant gram-negative bacterial infection

Interventions

None:Treated with polymyxin B

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. = 18 years old; 2. CRO infected persons confirmed or suspected to be diagnosed by clinical and microbiological culture, mNGS and other new technologies; 3. Patients treated with polymyxin B intravenously; 4. Participate in the study voluntarily and sign the informed consent form; If the subject has no ability to understand or sign the informed consent form, his/her legal representative will act as his/her agent for the informed process and allow him/her to participate in the study; If the subject is illiterate, the witness is required to witness the informed process and decide to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Those with positive CRO culture and no evidence of infection; 2. Pregnant or nursing; 3. Those who only use polymyxin B locally (e.g. intraventricular administration, inhalation, etc.); 4. Those who have used or combined with polymyxin E sulfate or polymyxin E sodium methanesulfonate before using polymyxin B; 5. Patients with polymyxin B for less than 3 days.

Design outcomes

Primary

MeasureTime frame
plasma concentration;pharmacokinetic parameters;

Secondary

MeasureTime frame
efficacy;nephrotoxicity;28-day mortality;

Countries

China

Contacts

Public ContactYu Yunsong

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

yvys119@zju.edu.cn+86 13805790432

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026