Skip to content

Optimizing Polymyxin Therapy for Critically Ill Patients in Hainan Through the PPK-PD-PG Model

Optimizing Polymyxin Therapy for Critically Ill Patients in Hainan Through the PPK-PD-PG Model

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104126
Enrollment
Unknown
Registered
2025-06-11
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Gram-negative bacterial infection in critically ill patients

Interventions

Treatment group: Receiving standard-dose polymyxin therapy.:None

Sponsors

Hainan Provincical People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with intracranial infections, diagnosed based on the presence of two or more of the following criteria: (1) Positive cerebrospinal fluid (CSF) culture results; (2)Body temperature above 38°C or below 36°C, accompanied by positive meningeal irritation signs (nuchal rigidity, positive Kernig's sign, and positive Brudzinski's sign), headache, or vomiting; (3) CSF sample showing positive changes, including a white blood cell count exceeding 1,000 × 10^6 cells/L, and glucose levels below 2.2 mmol/L or less than 40% of the blood glucose level. 2. Patients who have received polymyxin for more than 4 days; 3. Adult patients aged =18 years; 4. Patients who have provided consent and signed the informed consent form; 5. Patients with continuous therapeutic drug monitoring data during the study period.

Exclusion criteria

Exclusion criteria: 1. Individuals with severe cardiac, pulmonary, or liver dysfunction (aspartate aminotransferase or alanine aminotransferase levels exceeding 40 U/L) and/or renal failure (serum creatinine levels exceeding 106 µmol/L), or those with a history of allergy to polymyxin; 2. Pregnant women; 3. Patients with incomplete or unreliable therapeutic drug monitoring data during the study period.

Design outcomes

Primary

MeasureTime frame
Blood concentration;Drug clearance;

Secondary

MeasureTime frame
Healing conditions;

Countries

China

Contacts

Public ContactMin Wang

Hainan Provincial People 's Hospital

wangmin2020@hainmc.edu.cn+86 157 9907 7523

Outcome results

None listed

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