A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia

NCT06670872 | Not Yet Recruiting FDA Drug

• 1 other identifier: M2024219
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This study intends to evaluate the efficacy and safety of eravacycline-based combination therapy in real words for Chinese patients with CRAB pneumonia, providing data reference for clinical treatment of CRAB pneumonia.

Conditions

Pneumonitis; Acinetobacter Baumannii

Keywords

Eravacycline

Outcome Measures

Primary Outcomes (1)

• clinical efficacy at the end of treatment

  The primary endpoint is the clinical efficacy at the end of treatment (within 24 hours after the last dose of the trial medication) for all patients who have completed the trial according to the protocol. Clinical efficacy is assessed and the clinical response rate is calculated. Clinical response is evaluated by PI，and defined as an improvement, reduction, or disappearance of the patient's multiple symptoms and signs compared to before treatment, along with improvement or normalization of imaging findings. Clinical response rate = (number of patients with symptom relief) / (total number of patients included in the study).

  up to the end of treatment, up to 4 weeks(estimation)

Secondary Outcomes (3)

• Incidence Rate of Adverse Event

  up to the end of treatment, up to 4 weeks(estimation)

• The microbiological clearance rate

  up to the end of treatment, up to 4 weeks(estimation)

• The all cause mortality rate

  28 days

Study Arms (1)

Eravacycline combination therapy group

Eravacycline is administered intravenously at a dosage of 1mg/kg, once every 12 hours. The duration of intravenous infusion is approximately 60 minutes.The combined drugs include sulbactam or compound preparations containing sulbactam, polymyxin B, beta-lactam antibiotics, etc., used according to their instructions for use or clinical practice guidelines.

Drug: Eravacycline combination therapy group

Interventions

Eravacycline combination therapy group DRUG

Physicians determine the combination regimen of eravacycline, which may include sulbactam or compound preparations containing sulbactam, polymyxin B, beta-lactam antibiotics, etc., based on the pathogen identification and susceptibility results, and the China Guidelines for Diagnosis, Treatment, and Prevention of Infections Caused by Carbapenem-Resistant Gram-Negative Bacteria." The combined drugs are used according to their instructions for use or clinical practice guidelines.

Eravacycline combination therapy group

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 proven or suspected diagnosed of carbapenem-resistant Acinetobacter baumannii pneumonia, who are 18 years of age or older.

You may qualify if:

• Aged 18 years or older.
• Voluntarily participating in this study and signing an informed consent form. If the subject is unable to read and/or sign the informed consent form due to lack of capacity or other reasons, the informed process and the informed consent form must be signed by their legal guardian.
• Patients with clinical manifestations and imaging results consistent with bacterial pneumonia, and who are expected to benefit from antimicrobial treatment. Suspected carbapenem-resistant Acinetobacter baumannii infection or Acinetobacter baumannii detected in two consecutive sputum cultures (at least one of which must be from bronchoalveolar lavage or endotracheal aspirate), with resistance to carbapenems.
• Patients who have been treated with eravacycline for at least 3 days.

You may not qualify if:

• The investigator believes that there are any medical history, current condition, treatment, abnormal laboratory test results, or other situations that may affect the trial results, interrupt the trial process (or the subject cannot complete all trial requirements, operations, and visits), or increase the risk to the subject from receiving the trial medication, including patients with terminal illness, or evidence of an immediately life-threatening disease.
• Patients with a history of allergic reactions to tetracyclines or any excipients contained in the formulation of the study medication.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wang Fei, doctor

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Fei, doctor

CONTACT

13671304203; wangf78@139.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 1, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

CN (2)