Eravacycline Combination Therapy for MRAB

Pneumonia, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282835
• Other study ID #: 2023KY242
• Status: Recruiting
• Start date: January 26, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Fujian Medical University Union Hospital
• Contact: Hui Zhang, PhD
• Phone: +86 130 1572 3860
• Email: xhzh[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial
• Pulmonary Infection

Intervention

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.

Locations

Country	Name	City	State
China	Fujian Medical University Union hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The microbiological clearance rate	The microbiological clearance rate at the end of treatment	within 14days
Secondary	The all-cause mortality rate within 28 days	The all-cause mortality rate within 28 days	28 days
Secondary	"Incidence Rate of Adverse Event	safety data according to CTC-AE	28days