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Clinical study for high-dose tigecycline in the treatment of multi-drug resistant Gram-negative bacilli hospital-acquired pneumonia

Clinical study for high-dose tigecycline in the treatment of multi-drug resistant Gram-negative bacilli hospital-acquired pneumonia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025792
Enrollment
Unknown
Registered
2019-09-08
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-09

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

Conditions

HAP

Interventions

Standard dose group:Standard dose of tigecycline
High dose group:High dose tigecycline

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years male and female; 2. Clearly diagnosed as HAP or VAP, HAP is defined as symptoms that appear after 48 hours or more of admission, or symptoms that appear 7 days or less after discharge (first hospitalization time <=3 days). VAP is defined as pneumonia 48 hours or more after tracheal intubation; 3. Bacterial culture of qualified lower respiratory tract specimens is clearly multi-drug resistant Gram-negative bacilli infection; 4. tigecycline sensitive or intermediate, tigecycline is used according to clinical needs; 5. Weight 45 kg to 90 kg; 6. Subjects volunteered to participate and signed informed consent, and the process of signing the informed consent was in accordance with GCP requirements.

Exclusion criteria

Exclusion criteria: 1. patients with known or suspected P. aeruginosa infection; 2. using glucocorticoids (equivalent to 20 mg of prednisone daily for more than 2 weeks) or immunosuppressants, or immunocompromised individuals such as HIV-positive; 3. The patient has an allergic reaction to tigecycline or tetracycline; 4. the person is dying and cannot complete the course of treatment.

Design outcomes

Primary

MeasureTime frame
28-day prognosis;

Countries

China

Contacts

Public ContactYuhong Chen

The Fourth Hospital of Hebei Medical University

272409990@qq.com+86 13833466587

Outcome results

None listed

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