Clinical trial
The Effectiveness and Safety Study of Eravacycline Combination Therapy for Multidrug-Resistant Acinetobacter Baumannii Pneumonia
Name
2023KY242
Description
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
Trial arms
Trial start
2024-01-26
Estimated PCD
2024-10-31
Trial end
2024-12-31
Status
Recruiting
Treatment
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.
Arms:
Eravacyline combination
Size
20
Primary endpoint
Clinical Responded Rate
28 days
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-02-28
1 organization
1 product
4 indications
Organization
Fujian Medical University Union HospitalProduct
EravacyclineIndication
Pulmonary InfectionIndication
PneumoniaIndication
BacteriaIndication
Acinetobacter baumannii