A prospective, multicenter, open study of pharmacokinetics and safety of polymyxin B against Carbapenem-resistant gram-negative bacterial infection in children

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100043270

Enrollment

Unknown

Registered

2021-02-09

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-06-07

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

Conditions

Infectious Disease

Interventions

treatment:TDM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as infectious Disease, and pathogens are identified as carbapene-resistant gram-negative bacteria; 2. Aged 0-18 years; 3. Clinical application of polymyxin B at least four times; 4. The voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. Known history of allergies including to any of polymyxin B, colistin, penicillin, cephalosporins, carbapenems, heparin and food, etc.; 2. Difficult to follow the protocol; 3. May induce safety issues after polymyxin B treatment; 4. Have applied neurotoxicity drugs; 5. History of seizures or convulsions; 6. Applied tigecycline within thee days or plan to use tigecucline; 7. Difficult to acquired blood for TDM.

Design outcomes

Primary

Measure	Time frame
plasma concentration;	—

Countries

China

Contacts

Public ContactJing Zhang

Huashan Hospital affiliated to Fudan University

liuxiaofen227@163.com+86 13816357098

Outcome results

None listed

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