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Clinical study on the adjuvant treatment of multidrug-resistant gram-negative bacilli infection in central nervous system by intracerebroventricular or intrathecal injection of sodium polycolistin E mesylate

Clinical study on the adjuvant treatment of multidrug-resistant gram-negative bacilli infection in central nervous system by intracerebroventricular or intrathecal injection of sodium polycolistin E mesylate

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049839
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Central nervous system infection with multi-drug-resistant gram-negative bacilli

Interventions

Experimental group:The test group was given ITH or IVT injections of polymyxin E sodium methanesulfonate on the basis of control group
Control Group:Polymyxin E Sodium Mesylate for Injection

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 79 years; 2. In line with the American Infectious Diseases Association (IDSA) diagnostic criteria for central nervous system infections-carbapenem-resistant gram-negative bacilli infections; 3. Due to clinical needs, it is necessary to receive combined antibiotic therapy based on polymyxin E sodium methanesulfonate; 4. Agree to participate in the trial and sign the relevant informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver and kidney dysfunction; 2. Patients with a history of allergies to colistin E sodium methanesulfonate or other combined use of antibacterial drugs and their excipients; 3. Female patients during pregnancy, lactation or perinatal period; 4. Dying patients with brain death and unstable vital signs; 5. The drugs that the patient is using and must use may seriously affect the efficacy of the trial drug or increase its adverse reactions; 6. The patient and (or) the legal representative sign the Do Not Rescue (DNR), or decide to withdraw the life support treatment (withdraw) or limit the life support treatment intensity (withhold) and sign the relevant informed consent; 7. The patient has participated in a clinical intervention trial in the past 3 months; 8. The patient is a researcher or his immediate family, etc., where there may be improper informed consent; 9. Patients who are considered unsuitable to participate in this trial by the attending doctor.

Design outcomes

Primary

MeasureTime frame
cure rate of central nervous system infection;

Countries

China

Contacts

Public ContactFeng Guang

Henan Provincial People's Hospital

fgwxh@163.com+86 18903711799

Outcome results

None listed

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