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A single-center, single-arm study of colimycin for the rescue treatment of severe pneumonia caused by carbapenem-resistant gram-negative bacterial infection

A single-center, single-arm study of colimycin for the rescue treatment of severe pneumonia caused by carbapenem-resistant gram-negative bacterial infection

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055546
Enrollment
Unknown
Registered
2022-01-11
Start date
2022-01-11
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

severe pneumonia

Interventions

experimental group:After enrollment, the subjects entered the dosing observation period and received conventional treatment + study drug treatment (colimycin)

Sponsors

Department of Critical Care Medicine of West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The subject or the legal representative of the subject fully understands the purpose, nature, methods and possible adverse reactions of the trial, and is 18 years and over, and signs an informed consent form; 2. Severe pneumonia caused by carbapenem-resistant gram-negative bacteria infection is diagnosed by clinical symptoms, laboratory examination and imaging examination; 3. After applying the best clinical treatment plan available, it is clinically judged that the treatment is invalid or the disease has progressed.

Exclusion criteria

Exclusion criteria: 1. Allergy to macrolide drugs; 2. Patients with severe gastrointestinal diseases that affect the intake and absorption of study drugs, including but not limited to: severe diarrhea; patients with abnormal liver function and Child-Pugh score of C; 3. Those who are participating in other clinical research within 4 weeks before screening; 4. The investigator believes that the subject has any other circumstances that cannot allow this research protocol to proceed safely.

Design outcomes

Primary

MeasureTime frame
mortality;

Secondary

MeasureTime frame
the length of hospital stay;the length of ICU stay;

Countries

China

Contacts

Public ContactWu Qin

Department of Critical Care Medicine of West China Hospital, Sichuan University

qinwu0221@gmail.com+86 18980605920

Outcome results

None listed

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