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Precision Dosing Strategies of Amikacin for Drug-Resistant Bacterial Infections

Precision Dosing Strategies of Amikacin for Drug-Resistant Bacterial Infections

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088648
Enrollment
Unknown
Registered
2024-08-22
Start date
2024-09-02
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Infectious Disease

Interventions

Amikacin treatment group:NA

Sponsors

Huashan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Patients of any gender and weight; over 18 years old; (2) Patients with bloodstream infections, infective endocarditis, pulmonary infections (including hospital-acquired pneumonia/ventilator-associated pneumonia), complex intra-abdominal infections, central nervous system infections, skin and soft tissue infections, bone and joint infections, etc. caused by multi-drug resistant Gram-negative bacillus infections that have been confirmed or suspected based on clinical symptoms, signs, laboratory tests and pathogenic microorganism tests; (3) Patients who need to apply amikacin for clinical reasons and are willing to undergo therapeutic drug concentration monitoring of amikacin; (4) Those who understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who have used nephrotoxic drugs (such as vancomycin, polymyxins, etc.) within 3 days before the start of amikacin treatment or are expected to use them during the study period; (2) Those whose course of amikacin treatment is less than 5 days (except for those undergoing hemodialysis and peritoneal dialysis); (3) Those who have participated in other clinical studies within the previous 3 months.

Design outcomes

Primary

MeasureTime frame
plasma concentration;

Countries

China

Contacts

Public ContactXiaofen Liu

Huashan Hospital affiliated to Fudan University

liuxiaofen227@163.com+86 131 2058 1882

Outcome results

None listed

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