Eravacycline Combination Therapy for MRAB

Last updated: February 21, 2024
Sponsor: Fujian Medical University Union Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Bronchitis (Pediatric)

Treatment

Eravacycline Injection

Clinical Study ID

NCT06282835
2023KY242
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 trialrequirements, operations, and visits), or increase the subject's risk with theexperimental medication. Patients with terminal illnesses or evidence of immediatelylife-threatening diseases are excluded;
  5. Patients with a history of allergic reactions to tetracyclines or any excipients inthe investigational drug formulation

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Eravacycline Injection
Phase:
Study Start date:
January 26, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Fujian Medical University Union hospital

    Fuzhou, Fujian 350000
    China

    Active - Recruiting

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