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A prospective multi-center clinical observation study of therapeutic drug monitoring of norvancomycin

A prospective multi-center clinical observation study of therapeutic drug monitoring of norvancomycin

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049544
Enrollment
Unknown
Registered
2021-08-02
Start date
2021-08-02
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Bacterial Infection

Interventions

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients have been diagnosed as gram-positive infections and treated by norvancomycin in single or combination use: 2. Unlimited gender and age >= 18 years old; 3. The duration of norvancomycin is above 5 days and performed therapeutic drug monitoring (TDM); 4. Patient has signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Received effective drugs for gram-positive cocci such as methicillin-resistant Staphylococcus within 72 hours before enrollment, such as vancomycin, teicoplanin, linezolid, fusidic acid, tigecycline, Systemic antibacterial therapy such as tropomycin for more than 24 hours; 2. Those infected with gram-positive cocci such as methicillin-resistant Staphylococcus; 3. Those without norvancomycin blood concentration monitoring; 4. Pregnant or breastfeeding women; 5. Patients taking nephrotoxic drugs such as aminoglycosides or polymyxins in combination; 6. Those who lack the clinical and laboratory evaluation indicators of infection and cannot evaluate the efficacy and safety (see Annex 1 "Diagnosis of Infectious Diseases"); 7. Participated in other clinical investigators in the past three months.

Design outcomes

Primary

MeasureTime frame
norvancomycin concentration;Clinical efficacy;Pathogen;Serum creatine;urinalysis;

Countries

China

Contacts

Public ContactGuo Beining , Chen Yijian

Huashan Hospital, Fudan University

guobeining@aliyun.com+86 21 52888198

Outcome results

None listed

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