HAP or VAP
Conditions
Interventions
Group 1:Eravacycline Hydrochloride for Injection
Group 2:Eravacycline Hydrochloride for Injection
Group 3:Eravacycline Hydrochloride for Injection
Group 4:Eravacycline Hydrochloride for Injection
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) The subject (or their legal guardian) voluntarily signs an informed consent form; (2) Patients aged 18 to 80 years inclusive; (3) Patients diagnosed with HAP/VAP must meet the following conditions: a) Hospitalization for more than 48 hours or re-hospitalization within less than 7 days after discharge, or patients with acute pulmonary parenchymal infection occurring 48 hours after oral or nasal tracheal intubation or tracheotomy and mechanical ventilation; b) Chest X-ray (or computed tomography CT) obtained within 72 hours before randomization shows new or progressive infiltrates, consolidations, or ground-glass opacities; c) At least two of the following clinical symptoms/signs are present: i. New or worsening cough; ii. Production of purulent sputum or tracheal secretions; iii. Physical examination findings consistent with pneumonia/pulmonary consolidation (such as moist rales, dry rales, bronchial breathing sounds, wheezing, dull percussion); iv. Dyspnea, tachypnea (respiratory rate >25 breaths per minute) or hypoxemia (oxygen saturation 15%. (4) There are clear microbial culture results indicating carbapenem-resistant Acinetobacter baumannii (CRAB) and/or carbapenem-resistant Klebsiella pneumoniae (CRKP), and the susceptibility results indicate sensitivity to Eravacycline.
Exclusion criteria
Exclusion criteria: (1) Confirmed or suspected community-acquired bacterial pneumonia or viral pneumonia, active pulmonary tuberculosis; (2) Known or suspected allergy to tetracycline drugs or derivatives (including tigecycline), or any contraindications or allergic constitution; (3) For those who have previously received empirical antimicrobial treatment, the duration of antimicrobial treatment (excluding tetracycline antibiotics) exceeds 24 hours within 72 hours before randomization, and the symptoms/signs of infection are relieved after treatment; (4) Patients undergoing hemodialysis or peritoneal dialysis; (5) Invasive aspergillosis, mucormycosis, or other invasive fungal diseases; (6) Concurrent central nervous system infections (such as meningitis, brain abscess, post-surgical infection of cerebrospinal fluid shunt or shunt device infection); (7) Concurrent refractory septic shock, and persistent hypotension after adequate fluid resuscitation or vasopressor medication before randomization (despite the use of vasoactive drugs, the mean arterial pressure is still 0.15 µg·kg-1·min-1 or dobutamine >5 µg·kg-1·min-1); (8) Obvious liver disease (including known acute viral hepatitis or hepatic encephalopathy), or signs of liver disease and/or the following abnormal laboratory test values: Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) more than 5 times the upper limit of normal, or AST and/or ALT more than 3 times the upper limit of normal and total bilirubin more than 2 times the upper limit of normal, or total bilirubin more than 3 times the upper limit of normal; (9) Received oral or intravenous tetracycline drug treatment within one week before inclusion; (10) Participants who have participated in other clinical trials within 30 days before the first dose of medication; (11) Underlying respiratory diseases that lead to structural lung damage or may interfere with the assessment of treatment response, or diseases that hinder the clearance of lung secretions: a) Cystic fibrosis, granulomatous disease, pulmonary embolism, lung cancer; b) Lung abscess, empyema or obstructive pneumonia, hemoptysis, severe asthma; c) NYHA class III-IV heart failure; d) Lung or heart transplant recipients; (12) Patients with an expected survival time of less than 14 days for any reason; (13) History of epileptic seizures; (14) Patients without indications for bronchoscopy or treatment, or those with contraindications to bronchoscopy, or those who do not agree to undergo bronchoscopy; (15) Pregnant or lactating women, patients who may become pregnant within one month after medication; male participants who do not agree to take reliable contraceptive measures throughout the study period; (16) Any situation that the investigator believes may increase the risk to the subject or interfere with the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma;Drug concentration in pulmonary bronchial fluid; | — |
Countries
China
Contacts
Public ContactJin Hu, Jing Zhang
Neurosurgery Department,Phase I Clinical Research Center of Huashan Hospital, Fudan University
Outcome results
None listed