Antibiotic Therapy for Infectious Diseases

Recruiting

• Conditions: Infectious Disease

• Registration Number: NCT04937894
• Lead Sponsor: Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-01
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-23
• Last Update Submitted: 2021-06-23
• Study First Posted: 2021-06-24
• Last Update Posted: 2021-06-24
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate constant for tigecycline distribution	Through study completion, an average of 3 days	Pharmacokinetics of tigecycline
Adverse events	Through study completion, an average of 15 days	Drug-related adverse events and serious adverse events
Pharmacokinetics of tigecycline	Through study completion, an average of 3 days	clearance in L/h
The ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC).	Through study completion, an average of 3 days	PD target

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wei Zhao; 🇨🇳 Jinan, Shandong, China