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Pharmacokinetic study of colistin sulfate in ICU patients

Pharmacokinetic study of colistin sulfate in ICU patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094485
Enrollment
Unknown
Registered
2024-12-24
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Gram-negative bacterial infection

Interventions

Gram-negative drug-resistant bacterial infection patients:Blood samples were collected at different time points for drug concentration monitoring.

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old. 2.Diagnosed with severe infections (such as sepsis, pneumonia, intra-abdominal infections) caused by Gram-negative drug-resistant bacteria. 3.Receiving treatment with colistin sulfate (including loading and maintenance doses), with an expected treatment duration of >= 48 hours. 4.ICU inpatients with stable conditions, capable of undergoing blood sample collection. 5.Consent to participate in the study and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Allergic to any component of colistin sulfate for injection. 2.Pregnant women, breastfeeding women, or patients planning to become pregnant in the near future. 3.Inability to collect sufficient blood samples due to medical conditions or technical reasons. 4.Patients deemed unsuitable for participation in the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Plasma concentration;Serum Biochemistry;Coagulation Function;Arterial Blood Gas Analysis;Electrocardiogram;Chest Computed Tomography;

Secondary

MeasureTime frame
Vital signs;Complete Blood Count;

Countries

China

Contacts

Public ContactYun Cai

Chinese PLA General Hospital

caicai_hh@126.com+86 10 6693 7166

Outcome results

None listed

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