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Study on the efficacy and safety of different doses of tigecycline in severely ill patients with multi-drug resistant bacterial infection

Study on the efficacy and safety of different doses of tigecycline in severely ill patients with multi-drug resistant bacterial infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046950
Enrollment
Unknown
Registered
2021-05-31
Start date
2020-08-01
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

Severe infection

Interventions

Group A (standard dose) :The first dose of 100mg + 0.9% NaCl 100ml ivgtt, a constant infusion time of 1 hour. After 50 mg + 0.9% NaCl 100 ml q12h ivgtt, a constant infusion time of 1 hour.
Group B (medium dose) :The first dose of 200mg + 0.9% NaCl 200ml ivgtt, a constant infusion time of 1 hour. Then 100 mg + 0.9% NaCl 100 ml ivgtt, a constant infusion time of 1 hour.
Group C (high dose) :The first dose of 200mg + 0.9% NaCl 200ml ivgtt, a constant infusion time of 1 hour. Then 100 mg + 0.9% NaCl 100 ml q12h ivgtt, a constant infusion time of 1 hour.

Sponsors

The Second Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Severe conditions require ICU treatment or have been treated in the ICU. The diagnosis of complex abdominal infections, complex skin and soft tissue infections, and hospital-acquired pneumonia have been treated with broad-spectrum antibiotics for more than 7 days. The infection has not been effectively controlled. Progressive increase; 2. The bacteria cultured were multi-drug resistant, pan-resistant, and fully resistant bacteria (except Pseudomonas aeruginosa and Proteus).

Exclusion criteria

Exclusion criteria: 1. Tigecycline is a non-intravenous patient; 2. Severe liver dysfunction (Child3); 3. Pregnant, lactating women; 4. Patients with sepsis considering a primary disease infection as a urinary tract infection should be excluded.

Design outcomes

Primary

MeasureTime frame
Tigecycline serum drug concentration;white blood count;bacterial culture;procalcitonin;glutamic-pyruvic transaminase;albumin;Bilirubin;creatinine;

Secondary

MeasureTime frame
c reactive protein;

Countries

China

Contacts

Public ContactWang Hongliang

The Second Affiliated Hospital of Harbin Medical University

icuwanghongliang@163.com+86 15045377888

Outcome results

None listed

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