Eravacycline Combination Therapy for MRAB

The Effectiveness and Safety Study of Eravacycline Combination Therapy for Multidrug-Resistant Acinetobacter Baumannii Pneumonia

The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.

Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time

Study Overview

• Status: Recruiting
• Conditions: Pneumonia, Bacterial; Pulmonary Infection; Acinetobacter Baumannii
• Intervention / Treatment: Drug: Eravacycline Injection

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Hui Zhang, PhD; Phone Number: +86 130 1572 3860; Email: xhzh@fjmu.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Hui Zhang, Phd; Phone Number: 13015723860; Email: xhzh@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study plans to include patients diagnosed with CRAB pneumonia who seek medical attention at the Intensive Care Medicine Department of Fujian Medical University Union Hospital from January 2024 to April 2024

Description

Inclusion Criteria:

1. ≥18 years old;
2. Meets the diagnostic criteria for pneumonia specified by the Chinese Medical Association Respiratory Branch.
3. CRAB is identified or predominant pathogenic bacteria, and drug sensitivity test indicates that Eravacycline is sensitive to the strain;
4. Patients expected to receive Eravacycline for ≥4 days;
5. Has already signed the informed consent

Exclusion Criteria:

1. Pregnant or lactating;
2. Concurrent intracranial infection, urinary tract infection, or bloodstream infection;
3. Individuals in a moribund state;
4. The investigator believes there is any medical history, current condition, treatment, laboratory abnormalities, or other circumstances that may affect the trial results, interrupt the trial process (or the subject's inability to complete all trial requirements, operations, and visits), or increase the subject's risk with the experimental medication. Patients with terminal illnesses or evidence of immediately life-threatening diseases are excluded;
5. Patients with a history of allergic reactions to tetracyclines or any excipients in the investigational drug formulation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Eravacyline combination

Drug: Eravacycline Injection; Eravacycline at the recommended dose and administration method according to the instructions: 1 mg/kg intravenous administration, every 12 hours. The intravenous infusion duration is approximately 60 minutes. For patients with severe liver impairment (Child-Pugh class C), administer 1 mg/kg of this product every 12 hours on the first day, followed by 1 mg/kg every 24 hours starting from the second day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Responded Rate	Complete the treatment, and meet one of the following criteria to be considered clinical respond: 1. Patient's oxygenation index is stable or improved; 2. Patients with a SOFA score <3 remain unchanged or decrease, and patients with a SOFA score ≥3 decrease by at least 30%; 3. Normal body temperature for more than 3 days; 4. Improvement in pulmonary imaging; 5. Infection indicators show a continuous downward trend for 3 consecutive day	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The microbiological clearance rate	The microbiological clearance rate at the end of treatment	within 14days
The all-cause mortality rate within 28 days	The all-cause mortality rate within 28 days	28 days
"Incidence Rate of Adverse Event	safety data according to CTC-AE	28days

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Principal Investigator: Hui Zhang, PhD, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Eravacyline
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial
• Other Study ID Numbers: 2023KY242

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes