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Clinical Study on the Treatment of Lower Respiratory Tract Infection With Pseudomonas Aeruginosa by Ceftazidime and Avibatam

Clinical Study on the Treatment of Lower Respiratory Tract Infection With Pseudomonas Aeruginosa by Ceftazidime and Avibatam

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06992102
Enrollment
500
Registered
2025-05-28
Start date
2022-01-01
Completion date
2025-01-01
Last updated
2025-05-28

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

Conditions

MDRPA

Brief summary

Multidrug-resistant Gram-negative bacteria (MDR-GNB) is emerging globally as a pathogen of concern in healthcare-associated infections (HAIs), and a threat to public health.There has been an alarming rise in the prevalence of MDR-GNB infections globally over the last decade.Multidrug-resistant or Carbapenem-resistant Pseudomonas aeruginosa (MDRPA or CRPA) are one of the major pathogens in the hospital setting,and are particularly challenging due to limited therapeutic options,associated with high mortality rates.Ceftazidime/avibactam(CAZ/AVI) combines the anti-pseudomonal cephalosporin ceftazidime and the novel non-β-lactam β-lactamase inhibitor avibactam,which are now available for the treatment of MDR-GNB infections and favorable outcomes have been reported in hospitalized patients with carbapenem-resistant Enterobacterales (CRE).However, there are only few publications available with a small sample size limit, focusing on the efficacy of CAZ/AVI for the treatment of CRPA or MDRPA infections.Therefore, a retrospective analysis was conducted to compare the clinical efficacy and microbiological efficacy of CAZ/AVI versus other antibiotics for the treatment of MDRPA infections.

Interventions

None listed

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* patients with MDRPA infection diagnosed by clinicians * patients treated with anti-Pseudomonas aeruginosa antibiotics for at least 72h * patients older than 18 years old.

Exclusion criteria

* Patients with human immunodeficiency virus infection, mental illness, a medication course of less than 72 hours, or incomplete data were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Clinical efficacy28 day after enrollmentThe clinical efficacy of the treatment was determined by two senior physicians with extensive clinical experience, who classified it as either effective (characterized by the resolution or significant improvement of clinical symptoms and signs, normalization or minimal residuals in pulmonary imaging, and normalization of inflammatory markers), uncertain or ineffective.

Secondary

MeasureTime frameDescription
Microbiological efficacy28 day after enrollmentMicrobiological efficacy was defined as eradication or reduction, indicated by the absence of MDRPA in lower respiratory tract secretion cultures post-treatment, or a decrease in bacterial load by more than 25% compared to pre-treatment levels. Microbiological ineffectiveness was defined as the continued presence of MDRAB in cultures after treatment and no change or an increase in bacterial load compared to pre-treatment levels.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026