NCT06670872

A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study intends to evaluate the efficacy and safety of eravacycline-based combination therapy in real words for Chinese patients with CRAB pneumonia, providing data reference for clinical treatment of CRAB pneumonia.

Detailed description

This study aims to include 50 patients proven or suspected diagnosed carbapenem-resistant Acinetobacter baumannii pneumonia at Peking University Third Hospital. The physician determines to use a combination regimen of eravacycline, including sulbactam or compound preparations containing sulbactam, polymyxin B, and β-lactam antibiotics, is considered. The clinical response rate at the end of treatment is the primary endpoint of the study; the secondary endpoints include the clearance rate of carbapenem-resistant Acinetobacter baumannii, the incidence of adverse events, and the all-cause mortality rate within 28 days.

Conditions

• Pneumonitis
• Acinetobacter Baumannii

Interventions

Type	Name	Description
DRUG	Eravacycline combination therapy group	Physicians determine the combination regimen of eravacycline, which may include sulbactam or compound preparations containing sulbactam, polymyxin B, beta-lactam antibiotics, etc., based on the pathogen identification and susceptibility results, and the China Guidelines for Diagnosis, Treatment, and Prevention of Infections Caused by Carbapenem-Resistant Gram-Negative Bacteria." The combined drugs are used according to their instructions for use or clinical practice guidelines.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study