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Application and promotion of active therapeutic drug monitoring (ATM) technology in the individualized dosing of vancomycin in the treatment of patients with gram-positive bacteria infection

Application and promotion of active therapeutic drug monitoring (ATM) technology in the individualized dosing of vancomycin in the treatment of patients with gram-positive bacteria infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046718
Enrollment
Unknown
Registered
2021-05-27
Start date
2021-05-25
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Gram Positive Bacteria Infection

Interventions

experimental group:ATM-guided dosing

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. There is no restriction on gender, age and weight; 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 bloodstream infections, infective endocarditis, lung infections (including community-acquired pneumonia, hospital-acquired pneumonia) caused by gram-positive bacteria, complicated abdominal infections, central nervous system infections, skin and soft tissue infections, urinary tract infections (Including acute pyelonephritis, complicated urinary tract infection), bone and joint infections and other patients, and the above-mentioned infections caused by gram-positive bacteria allergic to ß-lactam antibiotics; 3. Those who apply ATM technology for individualized and precise vancomycin medication and perform blood concentration detection; 4. The course of vancomycin treatment is more than 5 days; 5. Those who have obtained informed consent.

Exclusion criteria

Exclusion criteria: 1. Within 3 days before vancomycin treatment and combined or expected to use nephrotoxic drugs during the study period (such as polymyxin drugs, aminoglycoside drugs, etc.); 2. Within 72 hours before selection, had received effective drugs for the treatment of methicillin-resistant staphylococcus and other gram-positive cocci, such as norvancomycin, teicoplanin, linezolid, 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. Pregnant or breastfeeding women; 5. Those who lack clinical and laboratory evaluation indicators for infection, and cannot evaluate safety and efficacy; 6. Participants in other clinical trials in the past month.

Design outcomes

Primary

MeasureTime frame
Acute Kidney Injury Incidence;

Secondary

MeasureTime frame
Efficacy;

Countries

China

Contacts

Public ContactZhang Jing

Huashan Hospital, Fudan University

zhangj_fudan@163.com+86 21 52888190

Outcome results

None listed

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