Sepsis Clinical Trial
— TDM-RCTOfficial title:
Evaluation of the Efficacy and Safety of Antibiotic Therapeutic Drug Monitoring (TDM) in Patients With Difficult-to-Treat Gram-Negative Bacterial (DT-GNB) Infections
A prospective, open-label, randomized controlled trial will be conducted to evaluate a novel TDM-guided therapy in management of DT-GNB infections. We hypothesize that TDM-guided antibiotic therapy will reduce 14-day all-cause mortality by 6% (absolute risk reduction) in septic patients with DT-GNB infections, when compared to standard therapy. TDM for 11 antibiotics will be performed for all trial patients although test information will be withheld for the standard therapy arm. The primary aim is to compare the 14-day all-cause mortality rates of novel TDM-guided antibiotic dosing versus standard therapy.
Status | Recruiting |
Enrollment | 810 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 14-day All-Cause Mortality Rate | This is defined as death of any cause. Study aims to compare the difference in 14-day all-cause mortality rates from the day of randomization between both arms. | 14 Days | |
Secondary | Fever Resolution | This is defined as the days to defervescence. Study aims to compare the difference in the days to defervescence after initiation of targeted antibiotic therapy between both arms. | 14 Days | |
Secondary | Microbiological Treatment Cure of Difficult to Treat Gram-Negative Bacteria (DT-GNB) | This is defined as presence of sterile site culture or absence of intended bacterial growth in culture of infection site. Study aims to compare microbiological cure of difficult to treat GNB between both arms. | 14 Days | |
Secondary | Improved or Stabilized Sequential Organ Failure Assessment (SOFA) | This is defined as delta SOFA or change in SOFA score between day 1 (randomization) to day 14. Study aims to compare the changes in SOFA scores between the two arms. | 14 Days | |
Secondary | Incidences of Adverse Drug Reactions | Adverse Drug Reactions (ADRs) are defined as renal failure (defined using RIFLE criteria), Neurologic disorders (defined as altered mental status, peripheral neuropathy, or seizures in the absence of preexisting neurologic conditions, substance-related toxic effects, or infectious syndromes) and hematological disorders (defined as anemia (hemoglobin level <10 g/dL), leukopenia (white blood cell count <4500 cells/µL), or thrombocytopenia (platelet count <150 × 103/µL) with levels below patient's baseline and in the absence of bleeding or myelosuppressive therapies). Study aims to compare the incidences of ADRs between the two arms. | Start to End of Antibiotic Therapy (Up to 90 days from randomization, discharge or demise, whichever comes earliest) |
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