Clinical trial NCT06670872: A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia
Official title: A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pneumonitis
Acinetobacter Baumannii
Keywords: Eravacycline
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This study aims to include 50 patients proven or suspected diagnosed carbapenem-resistant Acinetobacter baumannii pneumonia at Peking University Third Hospital. The physician determines to use a combination regimen of eravacycline, including sulbactam or compound preparations containing sulbactam, polymyxin B, and β-lactam antibiotics, is considered. The clinical response rate at the end of treatment is the primary endpoint of the study; the secondary endpoints include the clearance rate of carbapenem-resistant Acinetobacter baumannii, the incidence of adverse events, and the all-cause mortality rate within 28 days.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older.
2. 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.
3. 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.
4. Patients who have been treated with eravacycline for at least 3 days.

Exclusion Criteria:

1. 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.
2. Patients with a history of allergic reactions to tetracyclines or any excipients contained in the formulation of the study medication.

Primary outcomes:
measure: clinical efficacy at the end of treatment
timeFrame: up to the end of treatment, up to 4 weeks(estimation)
Secondary outcomes:
measure: Incidence Rate of Adverse Event
timeFrame: up to the end of treatment, up to 4 weeks(estimation)
measure: The microbiological clearance rate
timeFrame: up to the end of treatment, up to 4 weeks(estimation)
measure: The all cause mortality rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Wang Fei, doctor
role: PRINCIPAL_INVESTIGATOR
References: