complicated intra-abdominal infections caused by carbapenem-resistant gram-negative bacilli
Conditions
Interventions
Eravacycline-based group:None
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Study participants >=18 years old, male or female; 2. Participation must be voluntary, and written informed consent is required. If a subject lacks capacity and cannot read and/or sign the informed consent form, the legal guardian must complete the informed consent process and sign on the subject’s behalf. (After study activation, research data may be collected only from subjects who have provided informed consent, unless the local ethics committee has approved a waiver of consent.); 3. Diagnosis of complicated intra-abdominal infection (cIAI) according to the 2021 "Technical Guiding Principles for Clinical Trials of Antibacterial Agents for cIAI."; 4. A qualified intra-abdominal specimen culture must demonstrate carbapenem-resistant Gram-negative bacteria (CRO) that are clinically judged to be the causative pathogen; 5. Must have failed the initial antibiotic therapy targeted at the CRO infection (i.e., the regimen selected within 48 h after the CRO susceptibility report) , defined by any one of the following:Discontinuation of the current anti-infective regimen for reasons other than cure or de-escalation;Anticipated clinical failure prompting the clinician to change the initial anti-infective therapy (IAT);Addition of another antibiotic directed at the CRO infection after =48 h of treatment;Need for additional paracentesis or abdominal surgery >48 h after IAT initiation because the infection source was not controlled;In-hospital death for any reason; 6. For the eravacycline cohort, eravacycline must have been administered for >=72 h; Traditional-Therapy (Historical-Control) Cohort – Matched cases will be selected if complete clinical data are available and the following criteria are met: 1.Age >= 18 years, stratified and matched to enrolled study-group cases by age (>= 65 years or = 20); 6.Complete clinical outcome data for assessment of therapeutic efficacy (clinical outcome, microbiological outcome, and overall efficacy evaluation) can be met.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are ineligible for enrollment in this study: 1. Those with an anticipated life expectancy of <=5 days ( only applicable to the prospective cohort); 2. Vulnerable populations other than critically ill patients, including individuals with psychiatric disorders, cognitive impairment, pregnant women, and illiterate persons; 3. Patients with a confirmed diagnosis of cIAI caused solely by Pseudomonas aeruginosa; 4. Individuals with a history of hypersensitivity to tetracyclines or any excipients in the investigational drug formulation, or for whom the study medication is contraindicated; 5. Those with concomitant invasive fungal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological clearance rate;All-cause mortality;Clinical response rate; | — |
Countries
China
Contacts
Public ContactLi Lifen
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed