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Therapeutic Drug Monitoring and Clinical Study of Polymyxin B in Elderly HAP/VAP Patients Infected with Carbapenem-Resistant Organism

Therapeutic Drug Monitoring and Clinical Study of Polymyxin B in Elderly HAP/VAP Patients Infected with Carbapenem-Resistant Organism

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034095
Enrollment
Unknown
Registered
2020-06-23
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

hospital-acquired pneumonia/ventilator-associated pneumonia

Interventions

polymyxin B:Polymyxin B is used to treat HAP/VAP caused by CRO

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with unlimited gender and weight, aged >= 65 years; 2. HAP / VAP patients confirmed or proposed to be caused by cro infection by clinical symptoms, physical signs, laboratory examination and pathogenic microorganism examination; 3. The patients who need to use polymyxin B and monitor the concentration of polymyxin B treatment drugs due to clinical needs; 4. Polymyxin B combined with other antimicrobial agents are also included in the group, such as ß - lactams, carbapenems, fluoroquinolones and other drugs for the treatment of drug-resistant gram-negative bacilli or combination of drug-resistant Gram-positive bacilli; 5. Patients who understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to polymyxin B; 2. Patients with gram-negative bacilli as colonizing bacteria without infection basis; 3. Patients who lack of clinical infection and laboratory evaluation indexes and cannot be evaluated for efficacy and safety; 4. Patients (such as vancomycin, aminoglycoside, etc.) who use nephrotoxic drugs within 3 days before starting the treatment of polymyxin B and who are combined or expected to use nephrotoxic drugs during the study period; 5. Patients with a course of polymyxin B less than 5 days (except hemodialysis and peritoneal dialysis patients); 6. Patients who participated in other clinical studies within the previous 3 months.

Design outcomes

Primary

MeasureTime frame
pathogenic bacterium;blood concentration;mortality;mortality;AE rate;

Secondary

MeasureTime frame
Demographic data;Vital signs;underlying disease;Concurrent drug;blood routine examination;Biochemical indexes;urine routine examination;C-Reactive Protein;procalcitonin;endotoxin;

Countries

China

Contacts

Public ContactHuili Zhu

Huadong Hospital affiliated to Fudan University

zhuhuili001@126.com+86 21-62483180

Outcome results

None listed

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