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Research on precision treatment strategies of anti-drug resistant bacterial infection drugs in high-risk populations of acute kidney injury

Research on precision treatment strategies of anti-drug resistant bacterial infection drugs in high-risk populations of acute kidney injury

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036579
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant bacterial infection

Interventions

experimental group:Based on ATM-GDR recommended dosage

Sponsors

Jing Zhang
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Part 1: The high-risk population of AKI diagnosed with drug-resistant gram-positive bacteria is based on vancomycin ATM-GDR Among the patients who have been diagnosed with methicillin-resistant Staphylococcus and other gram-positive cocci infections and have been treated with vancomycin, those who meet the following criteria will be the collection objects for this project: 1. Gender and weight are not limited; 2. The clinical symptoms, signs, laboratory examinations and pathogenic microbial examinations have been confirmed to be methicillin-resistant Staphylococcus aureus, coagulase-negative Staphylococcus, Enterococcus, Streptococcus viridans (endocarditis) and other aerobic leather Bloodstream infections, infective endocarditis, lung infections (including community-acquired pneumonia, hospital-acquired pneumonia), complicated abdominal cavity infections, central nervous system infections, skin and soft tissue infections, and urinary tract infections caused by blue-positive bacteria ( Including acute pyelonephritis, complicated urinary tract infections), bone and joint infections and other patients, as well as the above-mentioned infections caused by gram-positive bacteria allergic to ß-lactam antibiotics; 3. Those who use the ATM system for individualized and precise vancomycin medication and perform blood concentration detection; 4. Critically ill patients, elderly (>65 years old), autoimmune diseases, children and other high-risk groups of AKI; 5. The course of vancomycin treatment is more than 5 days; 6 Those who have obtained informed consent. Part 2: Polymyxin B-based ATM-GDR for AKI high-risk populations diagnosed with resistant Gram-negative bacteria 1. Gender and weight are not limited; 2. Patients who have been confirmed by clinical symptoms, signs, laboratory examinations, and pathogenic microbial examinations or are suspected of being diagnosed as extensively drug-resistant Gram-negative bacteria infection; 3. The clinically evaluated patients are high-risk groups for AKI; 4. Patients who use colistin B due to clinical needs and monitor the concentration of colistin therapeutic drugs; 5. Understand and sign informed consent.

Exclusion criteria

Exclusion criteria: Part 1: The high-risk population of AKI diagnosed with drug-resistant gram-positive bacteria is based on vancomycin ATM-GDR 1. Within 3 days before vancomycin treatment, and those who combined or expected to use nephrotoxic drugs during the study period (such as Vancomycin, aminoglycoside drugs, etc.); 2. Those who have received methicillin-resistant Staphylococcus and other gram-positive cocci within 72 hours before being selected are effective Drugs, such as norvancomycin, teicoplanin, linezolid, rifampicin, fusidic acid, tigecycline, daptomycin and other systemic antibacterial treatment for more than 24 hours; 3. Gram-positive bacteria such as MSSA or methicillin-resistant Staphylococcus are colonizing bacteria; 4. Those who have not monitored the blood concentration of vancomycin; 5. Vancomycin course of treatment <5 days (except for hemodialysis and abdominal dialysis); 6. Pregnant or breastfeeding women; 7. Lack of clinical and laboratory evaluation indicators of infection, unable to conduct safety and efficacy evaluation; 8. Nearly 1 month Participants in other clinical trials. Part 2: Polymyxin B-based ATM-GDR for AKI high-risk populations diagnosed with resistant Gram-negative bacteria 1. Those who are allergic to polymyxin drugs; 2. Gram-negative bacilli are colonizing bacteria without evidence of infection; 3. Within 3 days before the start of polymyxin B treatment, and those who have combined or are expected to use nephrotoxic drugs (such as vancomycin, aminoglycoside drugs, etc.) during the study period; 4. Polymyxin B course of treatment < 5 days (except for hemodialysis and peritoneal dialysis patients); 5. Participate in other clinical research in the previous 3 months.

Design outcomes

Primary

MeasureTime frame
Plasma drug concentration;Pathogen MIC;creatinine;

Countries

China

Contacts

Public ContactJing Zhang

Huashan Hospital Affiliated to Fudan University

zhangj_fudan@163.com+86 13816357098

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026