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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Adverse Event | safety data according to CTC-AE | up to the end of treatment, up to 4 weeks(estimation) |
| The microbiological clearance rate | The microbiological clearance rate is at the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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This study plans to include patients proven or suspected diagnosed of carbapenem-resistant Acinetobacter baumannii pneumonia, who are 18 years of age or older.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Fei, doctor | Contact | 13671304203 | wangf78@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang Fei, doctor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| up to the end of treatment, up to 4 weeks(estimation) |
| The all cause mortality rate | The all-cause mortality rate within 28 days | 28 days |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
|
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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