Antibiotic Therapy for Infectious Diseases

Infectious Disease Clinical Trial

Official title:

The Efficacy and Safety of Tigecycline for the Treatment of Infectious Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937894
• Other study ID #: 2021_TIG_001
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2021
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. However, the efficacy and safety data for tigecycline in infectious patients are lacking. The aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2025
• Est. primary completion date: July 1, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline

Exclusion Criteria:

1. severe liver dis- eases (e.g., Child-Pugh score C);

2. patients allergic to tetracycline and tigecycline;

3. those who have participated in other clinical trials, or those who are considered unsuitable by researchers;

4. pregnant women and lactating women.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• Tigecycline
Efficacy and safety of Tigecycline

Locations

Country	Name	City	State
China	Wei Zhao	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University	Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Drug-related adverse events and serious adverse events	Through study completion, an average of 15 days
Primary	Pharmacokinetics of tigecycline	clearance in L/h	Through study completion, an average of 3 days
Primary	Rate constant for tigecycline distribution	Pharmacokinetics of tigecycline	Through study completion, an average of 3 days
Primary	The ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC).	PD target	Through study completion, an average of 3 days
Secondary	fibrinogen levels in mg/dL		Through study completion, an average of 3 days
Secondary	prothrombin time	prothrombin time in second	Through study completion, an average of 3 days
Secondary	activated partial thromboplastin time	activated partial thromboplastin time in second	Through study completion, an average of 3 days
Secondary	international normalized ratio	international normalized ratio,INR	Through study completion, an average of 3 days
Secondary	blood platelet count	blood platelet count in ×10^9/L	Through study completion, an average of 3 days
Secondary	thrombin time	thrombin time in second	Through study completion, an average of 3 days