Antibiotic Therapy for Infectious Diseases
The Efficacy and Safety of Tigecycline for the Treatment of Infectious Diseases
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 24, 2021
June 1, 2021
4.1 years
June 17, 2021
June 23, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
fibrinogen levels in mg/dL
Through study completion, an average of 3 days
prothrombin time
Through study completion, an average of 3 days
activated partial thromboplastin time
Through study completion, an average of 3 days
international normalized ratio
Through study completion, an average of 3 days
blood platelet count
Through study completion, an average of 3 days
- +1 more secondary outcomes
Interventions
Efficacy and safety of Tigecycline
Eligibility Criteria
patients with severe infections
You may qualify if:
- critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline
You may not qualify if:
- severe liver dis- eases (e.g., Child-Pugh score C);
- patients allergic to tetracycline and tigecycline;
- those who have participated in other clinical trials, or those who are considered unsuitable by researchers;
- pregnant women and lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- Shandong Provincial Hospitalcollaborator
Study Sites (1)
Wei Zhao
Jinan, Shandong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of department of clinical pharmacy and pharmacology
Study Record Dates
First Submitted
June 17, 2021
First Posted
June 24, 2021
Study Start
June 1, 2021
Primary Completion
July 1, 2025
Study Completion
December 1, 2025
Last Updated
June 24, 2021
Record last verified: 2021-06