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Polymyxin B therapy based on Therapeutic drug monitoring in Carbapenem-Resistant Organism sepsis: a multicenter randomized controlled trial

Polymyxin B therapy based on Therapeutic drug monitoring in Carbapenem-Resistant Organism sepsis: a multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043208
Enrollment
Unknown
Registered
2021-02-08
Start date
2021-02-15
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

sepsis

Interventions

experimental group:PMB 75mg q12h ivgtt
control group:PMB 50mg q12h ivgtt

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged >= 18 and <=75 years; (2) Patients with sepsis caused by CRO infection (Sepsis 3.0 standard), including ventilator-associated pneumonia (VAP), hospital-acquired pneumonia (HAP), mediastinal infection, abdominal cavity/biliary tract infection, bloodstream infection, cranial Internal infection, surgical area infection or skin and soft tissue infection, etc.; (3) There is microbiological evidence and drug sensitivity results; (4) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who have started polymyxin B treatment before enrollment; (2) Patients who cannot obtain informed consent; (3) Patients who participate in other exploratory clinical studies at the same time; (4) Patients who are allergic to research antibiotics; (5) In the terminal stage of the disease, the expected survival is less than 3 months; (6) Pregnant women or patients who need to breastfeed; (7) Those who cannot receive active and comprehensive treatment.

Design outcomes

Primary

MeasureTime frame
14-day improvement rate;

Secondary

MeasureTime frame
14-day mortality;28-day mortality;AUC 24 hours and 72 hours after polymyxin administration;Clinical cure;Normal body temperature (below 37.5 degrees C, at least 3 days);Mechanical ventilation time;ICU hospital stay;Total length of stay;Bacteria removal rate;Superinfection;Diarrhea;Compliance rate of blood drug concentration level;Incidence of acute kidney injury;

Countries

China

Contacts

Public ContactTongwen Sun

The The First Affiliated Hospital of Zhengzhou University

suntongwen@163.com+86 13838516916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026