Eravacycline Combination Therapy for MRAB

Recruiting

• Conditions: Pulmonary Infection; Pneumonia, Bacterial; Acinetobacter Baumannii
• Interventions: Drug: Eravacycline Injection

• Registration Number: NCT06282835
• Lead Sponsor: Fujian Medical University Union Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-17
• Study Start: 2024-01-26
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eravacyline combination	Eravacycline Injection	-

Primary Outcome Measures

Name	Time	Method
Clinical Responded Rate	28 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fujian Medical University Union hospital; 🇨🇳 Fuzhou, Fujian, China