Using drug monitoring to improve treatment for tough bacterial infections
Evaluation of the Efficacy and Safety of Antibiotic Therapeutic Drug Monitoring (TDM) in Patients With Difficult-to-Treat Gram-Negative Bacterial (DT-GNB) Infections
This study is testing if using drug monitoring can help doctors choose the right antibiotics to save lives in patients with serious Gram-negative bacterial infections and sepsis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 810 (estimated) |
| Ages | 16 Years to 99 Years |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05942157 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of therapeutic drug monitoring (TDM) in guiding antibiotic therapy for patients suffering from difficult-to-treat Gram-negative bacterial infections, particularly those experiencing sepsis and hemodynamic instability. The study is designed as a prospective, open-label, randomized controlled trial comparing TDM-guided therapy to standard antibiotic treatment. By monitoring drug levels for 11 antibiotics, the trial aims to determine if TDM can significantly reduce 14-day all-cause mortality rates in septic patients. The findings could lead to a shift in treatment practices for managing severe bacterial infections.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 16 years or older who are receiving intravenous antibiotic therapy for at least three days.
Not a fit: Patients who are pregnant, receiving antibiotics only as prophylaxis, or on palliative care with a life expectancy of less than 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in patients with severe bacterial infections and improve overall treatment outcomes.
How similar studies have performed: While the concept of TDM is established, this specific application in difficult-to-treat Gram-negative infections is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 16 years or older * Receive intravenous therapy of the study antibiotics * Antibiotic treatment should be aimed for at least 3 days at time of inclusion Exclusion Criteria: * Pregnancy * Antibiotics cessation before first blood sample collection * Receiving antibiotics only as prophylaxis * On palliative care or with less than 48 hours of life expectancy
Where this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Tze Peng Lim, PhD — Singapore General Hospital
- Study coordinator: Tze Peng Lim, PhD
- Email: lim.tze.peng@sgh.com.sg
- Phone: +65 6326 6959
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.