Evaluating the use of tigecycline for severe infections
The Efficacy and Safety of Tigecycline for the Treatment of Infectious Diseases
This study is testing if the antibiotic tigecycline is safe and effective for critically ill patients with severe infections caused by tough-to-treat bacteria.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT04937894 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of tigecycline, a last-resort antibiotic, in critically ill patients suffering from severe infections caused by extensively drug-resistant bacteria. The study will utilize pharmacokinetics and omics to gather data on how well the antibiotic works and its safety profile in this patient population. By focusing on hospitalized individuals who are being treated with tigecycline, the research seeks to fill the existing gaps in efficacy and safety data for this treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill hospitalized males or nonpregnant females aged 18 years or older with severe infections being treated with tigecycline.
Not a fit: Patients with severe liver diseases, allergies to tetracycline or tigecycline, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the effectiveness and safety of tigecycline, potentially improving treatment options for patients with severe infections.
How similar studies have performed: While there is limited data on the specific use of tigecycline in this context, the study aims to address a significant gap in existing literature regarding its efficacy and safety.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- Wei Zhao — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Wei Zhao, Ph.D
- Email: zhao4wei2@hotmail.com
- Phone: 86053188383308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.