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Search / Trial NCT05942157

Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections

Launched by SINGAPORE GENERAL HOSPITAL · Jul 4, 2023

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

Sepsis Hemodynamic Instability Therapeutic Drug Monitoring Gram Negative Bacteria Beta Lactams Fosfomycin Fluoroquinolone Glycylcycline Dialysis

ClinConnect Summary

This clinical trial is studying a new way to guide antibiotic treatment for patients with tough-to-treat bacterial infections that can lead to serious conditions like sepsis. The researchers want to see if using a method called Therapeutic Drug Monitoring (TDM) can help improve survival rates compared to standard antibiotic therapy. The goal is to find out if TDM can reduce the number of patients who die within 14 days of treatment by 6%. In this trial, some patients will receive TDM-guided antibiotics, while others will receive the usual treatment without the benefit of TDM information.

To participate in this trial, individuals must be at least 16 years old and currently receiving specific antibiotics through an IV for at least three days. However, pregnant individuals, those on palliative care, or those who are not expected to live longer than 48 hours will not be eligible. Participants can expect to have their antibiotic levels monitored through blood tests during their treatment, which aims to ensure they receive the most effective doses. This research is important because it could lead to better treatment options for patients facing difficult infections.

Gender

ALL

Eligibility 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

About Singapore General Hospital

Singapore General Hospital (SGH) is a leading academic medical center in Singapore, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SGH plays a pivotal role in conducting cutting-edge studies that aim to improve patient outcomes and enhance medical knowledge across various specialties. With a strong focus on collaboration and multidisciplinary approaches, SGH leverages its extensive resources and expertise to facilitate rigorous clinical trials, ensuring the highest standards of safety and efficacy in the development of new treatments and therapies.

Locations

Singapore, Singapore

Singapore, Singapore

Patients applied

0 patients applied

Trial Officials

Tze Peng Lim, PhD

Principal Investigator

Singapore General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported