Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT06223100
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years old.
* Voluntary to participate in this study and signed informed consent. If the subject is unable to read and / or sign the informed consent due to incapacity or other reasons, the guardian of the subject is required to act as the agent of the informed process and sign the informed consent.
* In a state of low immune function:
* In this study, if the patient meets any of the following criteria, the patient 's immune function is considered to be low : 1 patients who have previously received solid organ transplantation ( liver, kidney, lung, heart ) ; 2 hematological malignancies ( leukemia, lymphoma ) ; 3 Patients received long-term immunosuppressive therapy, or used steroids that reached immunosuppressive doses within 21 months before screening ( ≥ 10 mg prednisone or \> 15 mg / kg / d hydrocortisone or d \> 3 mg / kg / d methylprednisolone, continuous d \> 5 days ) \[ 4,13 \]. 4 Severe infections occurred recently, leading to extremely low immune function.
* Infections caused by known or highly suspected multidrug-resistant pathogens (MDR), or gram-negative bacteria that are sensitive to eravacycline in adult patients with limited treatment options. The high-risk factors and standards of MDR met the definition of " Chinese expert consensus on prevention and control of nosocomial infection of multidrug-resistant bacteria "; multidrug-resistant bacteria (MDR) refer to bacteria that are resistant to three or more types of commonly used antibiotics that are usually sensitive. Multidrug resistance also includes pan-drug resistance (XDR) and pan-drug resistance (PDR).
* Patients treated with elastin ≥ 3 days.
Exclusion Criteria:
* Urinary tract infection.
* Clear culture results showed that microbial pathogens were not sensitive to test drugs (such as Pseudomonas aeruginosa, etc.).
* Patients whose expected survival time cannot exceed the study period.
* The researchers believe that there is any medical history, current condition, treatment, abnormal laboratory examination or other conditions that may affect the test results, interrupt the test process (or the subject cannot complete all the operations and visits required by the test) or accept the test drugs that will increase the risk of the subject. Patients with end-stage diseases have immediate life-threatening disease evidence.
* Patients with a history of allergic reactions to tetracyclines or any adjuvant contained in the study drug formula.
* Vulnerable groups other than critically ill patients, including people with mental illness, cognitive impairment, pregnant women, etc.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06223100
Study Brief:
Protocol Section:
NCT06223100