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Therapeutic Drug Monitoring and Clinical Study of Amikacin In Patients with infection by Gram-Negative Bacteria

Therapeutic Drug Monitoring and A Clinical Study of Amikacin In Patients with infection by Gram-Negative Bacteria

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025622
Enrollment
Unknown
Registered
2019-09-02
Start date
2019-12-02
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

Gram Negative Bacteria Infection

Interventions

single arm:Amikacin

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients have been diagnosed as gram-negative infections and treated by amikacin In accordance with the following requirements: 1) Unlimited gender, age and weight; 2) Confirm or suspect the patients of gram-negative bacteria (Pseudomonas aeruginosaAcinetobacter baumannii and enterobacteriaceae) infections by clinical symptoms, signs, laboratory and pathogenic microorganism examination, such as pulmonary infection, urinary tract infection, bloodstream infection, abdominal cavity infection, central nervous system infection; 3) Patients receive treatment of amikacin and therapeutic drug monitoring; 4) Patients with gram-negative infection who receive combination of amikacin and other antimicrobial agents, such as ß-lactams, carbapenems and fluoroquinolones. 5) Patients with informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients who are allergic to Amikacin; 2) Patients with colonized gram-negative bacteria and no basis of infection; 3) Pregnancy or breastfeeding women; 4) Patients receiving combination of amikacin and polymyxin, glycopeptide or sulfonamides; 5) Patients lacking of clinical infection and laboratory evaluation index and could not be evaluated the clinical efficacy and safety; 6) Treatment duration of amikacin less than 5 days (Except hemodialysis and peritoneal dialysis patients); 7) Unhospitalized patients; 8) Participate in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
effecacy and safety;

Countries

China

Contacts

Public ContactJing Zhang, Yuancheng Chen

Huashan Hospital, Fudan University

zhangj_fudan@163.com+86 021-52888190

Outcome results

None listed

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