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Intravenous plus nebulized polymyxins versus ceftazidime/avibactam for multi-drug-resistant Gram-negative bacteria pneumonia: a target trial emulation

Intravenous plus nebulized polymyxins versus ceftazidime/avibactam for multi-drug-resistant Gram-negative bacteria pneumonia: a target trial emulation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111039
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-10-24
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Multi-drug-resistant Gram-negative bacteria pneumonia patients

Interventions

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: ICU patients in seven tertiary A hospitals in Shandong Province who received intravenous administration combined with nebulized colistin or ceftazidime/avibactam from January 1, 2018, to July 31, 2025. 1. Patients with microbiologically confirmed MDR-GNB pneumonia. 2. Patients with an artificial airway. 3. Age >= 18 years.

Exclusion criteria

Exclusion criteria: 1.In vitro drug sensitivity tests showed that MDR-GNB was resistant to colistin or ceftazidime/avibactam, such as pan - drug resistant Acinetobacter baumannii, metallo - enzyme - producing CRO, Serratia marcescens, Proteus spp., Morganella spp., Burkholderia cepacia, etc. 2.Severe multiple organ failure, with an APACHE II score >=40 at enrollment. 3.Patients who had been treated with intravenous or nebulized polymyxins or ceftazidime/avibactam or polymyxins combined with ceftazidime/avibactam within 7 days before enrollment. 4.Acquired immune deficiency syndrome and human immunodeficiency virus carriers. 5.Patients with missing data more than 20%.

Design outcomes

Primary

MeasureTime frame
All-cause mortality at 30 day;

Secondary

MeasureTime frame
Proportion of patients with clinical response at 7 day;All-cause mortality at 14 day;Proportion of patients with clinical response at 14 day;14-Day clearance of MDR-GNB microorganisms;Incidence of acute kidney injury;Incidence of airway spasm during aerosolized colistin;Days in ICU;Total hospital length;Days on mechanical ventilation within 30 days;Days with RRT within 30 days;Days of vasopressors within 30 days;Days of antibiotics-free within 30 days;

Countries

China

Contacts

Public ContactZeng Juan

Shandong Provincial Hospital Affiliated to Shandong First Medical University

nine2652@163.com+86 151 6886 7561

Outcome results

None listed

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