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Analysis of PK/PD/TD in the treatment of infected population with polymyxin E sodium mesylate: a multicenter observational study

Analysis of PK/PD/TD in the treatment of infected population with polymyxin E sodium mesylate: a multicenter observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109123
Enrollment
Unknown
Registered
2025-09-12
Start date
2025-09-12
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Infection caused by carbapenem-resistant Gram-negative bacteria

Interventions

Polymyxin E methanesulfonate blood concentration observation group:None

Sponsors

Tongde Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Patients clinically diagnosed or highly suspected of CRGNB infection; 3. Intravenous use of colistin methanesulfonate (CMS) for at least 3 days; 4. Those who agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who fail to cooperate in undergoing blood collection and related tests within the specified time; 2.Cases with incomplete data; 3.Pregnant or lactating women; 4.Other situations that the researchers deem unsuitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Anti-infection effective rate;14-day or 28-day mortality rate;The effective and safe blood concentration threshold of polymyxin E;

Secondary

MeasureTime frame
LOS(length of hospital stay);PK/PD;Antimicrobial drug management indicators;Microbial reaction;The gene polymorphism of polymyxin e-methanesulfonic acid;Security Index;

Countries

China

Contacts

Public ContactYuexing Tu

Tongde Hospital of Zhejiang Province

Tuyuexing1988@163.com+86 571 8997 2333

Outcome results

None listed

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