NCT07084129 Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention
| NCT ID | NCT07084129 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-04-15 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Vancomycin may not be effective if blood levels of the medicine are too low. Vancomycin has potential side effects, including the possibility of injury to the kidney. These side effects usually happen when blood levels of vancomycin are too high. There are guidelines for the range of vancomycin blood levels doctors should target to treat an infection and lower the risk of side effects. Children with sepsis may metabolize vancomycin at different rates, faster or slower, than children who do not have sepsis. For these reasons, the current dosing strategy may lead to a higher risk of kidney injury or a risk of not adequately treating an infection in children with sepsis. The investigators' goal is to use new vancomycin dosing equations to improve the ability to select the right dose of vancomycin. The main questions this trial aims to answer are: 1. Is it feasible to use personalized models of vancomycin dosing in children with sepsis? 2. Will personalized models of vancomycin dosing achieve vancomycin blood levels in acceptable ranges?
Eligibility Criteria
Inclusion Criteria: 1. Age \>1 month and \<18 years 2. Weight \>5kg and \<50kg 3. Vancomycin intended duration of therapy ≥48 hours 4. Admitted to intensive care unit with suspected or confirmed sepsis 5. Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or resolved at the time of enrollment) Exclusion Criteria: 1. Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy 2. Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)\>1 3. Central nervous system infection 4. Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy) 5. Pregnancy 6. Patients on chronic dialysis therapy 7. Patients with known history of delayed vancomycin clearance based on local pharmacy records
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07084129 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 17 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07084129 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07084129 currently recruiting?
Yes, NCT07084129 is actively recruiting participants. Contact the research team at fitzgeraldj@chop.edu for enrollment information.
Where is the NCT07084129 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07084129 clinical trial?
NCT07084129 is sponsored by Children's Hospital of Philadelphia. The trial plans to enroll 20 participants.