Population pharmacokinetics of tigecycline in patients with carbapenem-resistant Enterobacteriaceae bloodstream infections
The Population Pharmacokinetics Study of Tigecycline and Pharmacokinetics- Pharmacodynamics Index in Patients With Carbapenem Resistant Enterobacteriaceae Bloodstream Infection
This study is testing if a high-dose of the antibiotic tigecycline can help critically ill patients with bloodstream infections from tough-to-treat bacteria feel better and survive longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Phramongkutklao College of Medicine and Hospital Academic / other |
| Locations | 1 site (Ratchathewi, Bangkok) |
| Trial ID | NCT06049771 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of tigecycline in patients suffering from bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (CRE). It focuses on critically ill patients who receive a high-dose regimen of tigecycline to assess its effectiveness in improving clinical outcomes and reducing mortality. Blood samples will be collected to analyze the pharmacokinetics and pharmacodynamics of the drug, aiming to optimize treatment protocols for this severe infection. The study is conducted at Phramongkutklao Hospital in Bangkok, Thailand.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 years and older who are diagnosed with bloodstream infections caused by CRE and are experiencing sepsis or septic shock.
Not a fit: Patients who are pregnant, breastfeeding, or have hypersensitivity to tigecycline will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with severe CRE bloodstream infections, potentially reducing mortality rates.
How similar studies have performed: Other studies have shown that high-dose tigecycline can improve clinical outcomes in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 20 years and older who were admitted at Phramongkutklao Hospital 2. Patients who were diagnosed bloodstream infection with CRE and who were sepsis or septic shock 3. Patients who received tigecycline loading dose 200 mg infusion for 1 hour and following maintenance dose 100 mg every 12 h infusion for 1 hour at least 48 hours and grant for blood collection Exclusion Criteria: 1. Pregnancy or Breastfeeding 2. Patients who cannot tolerant to the toxicity of tigecycline for example hypersensitivity to tigecycline or any component of the formulation 3. Patients who were infected with more than one isolated in blood culture at the same time
Where this trial is running
Ratchathewi, Bangkok
- Phramongkutklao Hospital — Ratchathewi, Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Sirapat Somsirikarnjanakoon, PharmD.
- Email: sirapat.rx@gmail.com
- Phone: 0982511524
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.