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NCT01786161 · ClinicalTrials.gov registry record · Phase 4
Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT01786161: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01786161 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01786161, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancomycin is debated in the literature. Since vancomycin is associated with slow bactericidal activity, it is important to closely monitor serum concentrations so as to achieve early target serum concentration, particularly when treating aggressive S. aureus infections. One study has shown that vancomycin infused continuously may enable faster and more consistent achievement of a therapeutic serum concentration when compared to intermittent infusion. A faster achievement in the goal serum vancomycin concentration would be a protective factor for intensive care unit mortality in patients with MRSA infection. Currently in the surgical ICU (SICU) of our institute, vancomycin is administered based on a vancomycin dosing nomogram. Less than fifty percent of the ICU patients following this nomogram achieved target vancomycin concentration of 15 after 24 hours. To better achieve target vancomycin concentration in 24 hours, we developed a new vancomycin dosing nomogram with a continuous infusion. The aim is to determine which of the two dosing nomogram is more efficient and safer for SICU patients.
Primary Outcome
The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV
Interventions
- DRUG Vancomycin continuous infusion
- DRUG Vancomycin intermittent dosing interval
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
Why NCT01786161 stopped before completion
NCT01786161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Vancomycin continuous infusion is the first listed.
NCT01786161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01786161 about?
NCT01786161 is a clinical study titled "Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients". Vancomycin is an essential antimicrobial which is frequently used in the ICU for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. Therefore, it is vital to optimize the dosing of vancomycin for this critically ill population. The most efficacious method of administering vancom...
What is the current status of trial NCT01786161?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2013-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01786161?
The interventions under investigation include: Vancomycin continuous infusion (DRUG), Vancomycin intermittent dosing interval (DRUG).
Who is sponsoring clinical trial NCT01786161?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01786161's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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