Antibiotic Therapy for Infectious Diseases

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infectious Disease
• Intervention / Treatment: Drug: Tigecycline

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Wei Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with severe infections

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Drug-related adverse events and serious adverse events	Through study completion, an average of 15 days
Pharmacokinetics of tigecycline	clearance in L/h	Through study completion, an average of 3 days
Rate constant for tigecycline distribution	Pharmacokinetics of tigecycline	Through study completion, an average of 3 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
fibrinogen levels in mg/dL		Through study completion, an average of 3 days
prothrombin time	prothrombin time in second	Through study completion, an average of 3 days
activated partial thromboplastin time	activated partial thromboplastin time in second	Through study completion, an average of 3 days
international normalized ratio	international normalized ratio，INR	Through study completion, an average of 3 days
blood platelet count	blood platelet count in ×10^9/L	Through study completion, an average of 3 days
thrombin time	thrombin time in second	Through study completion, an average of 3 days

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Tigecycline
• Other Study ID Numbers: 2021_TIG_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No