Skip to content

Clinical study of polymyxin E sodium mesylate in the treatment of carbapenem-resistant gram-negative bacteria (CRO) infection in critically ill patients

Clinical study of polymyxin E sodium mesylate in the treatment of carbapenem-resistant gram-negative bacteria (CRO) infection in critically ill patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103466
Enrollment
Unknown
Registered
2025-05-29
Start date
2025-03-21
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

carbapenem-resistant gram-negative bacteria (CRO) infection

Interventions

treatment group:Anti-infective treatment with polymyxin E sodium mesylate
control subjects:Treatment with antibiotics other than polymyxin E sodium mesylate such as cefoperazone/sulbactam, piperacillin/tazobactam, imipenem/cilastatin, merope

Sponsors

Hangzhou Linping Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. The pathogen was confirmed by microbiology to be CRO, and the antimicrobial susceptibility test was sensitive to CMS (the specimen was sputum culture, alveolar lavage fluid culture, blood culture, and urine culture); 3. The treatment time of CMS in the treatment group was = 72 hours.

Exclusion criteria

Exclusion criteria: 1. Age< 18 years old; 2. CRO colonization or contamination; 3. The treatment time of CMS in the treatment group was < 72 hours.

Design outcomes

Primary

MeasureTime frame
WBC, NEUT%, CRP, PCT, IL-6;The infection type, microbial species, and infection indicators;Bacterial clearance rate;

Secondary

MeasureTime frame
The days of ventilator use and ICU stay ;Safety evaluation;Vital signs: body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation;

Countries

China

Contacts

Public ContactLyu Cong

Hangzhou Linping Hospital of Traditional Chinese Medicine

22350078@qq.com+86 571 86381669

Outcome results

None listed

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