Eravacycline Combination Therapy for MRAB

NCT06282835 | Recruiting FDA Drug

• 1 other identifier: 2023KY242
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Infection; Pneumonia, Bacterial; Acinetobacter Baumannii

Keywords

Eravacyline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The microbiological clearance rate

  within 14days

• The all-cause mortality rate within 28 days

  28 days

• "Incidence Rate of Adverse Event

  28days

Study Arms (1)

Eravacyline combination

Drug: Eravacycline Injection

Interventions

Eravacycline Injection DRUG

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.

Eravacyline combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating;
• Concurrent intracranial infection, urinary tract infection, or bloodstream infection;
• Individuals in a moribund state;
• 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;
• Patients with a history of allergic reactions to tetracyclines or any excipients in the investigational drug formulation

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Pneumonia, Bacterial

Interventions

eravacycline

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Zhang, PhD

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Zhang, PhD

CONTACT

+86 130 1572 3860; xhzh@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 28, 2024
• Study Start: January 26, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)