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NCT01196169 · ClinicalTrials.gov registry record · Phase 4
Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty
A Phase 4 study, sponsored by Mountain Home Research & Education Corporation.
- Terminated
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01196169: Clinical Trial Phase 4 study, sponsored by Mountain Home Research & Education Corporation.
NCT01196169 is a Phase 4 study that was terminated before completion, run by Mountain Home Research & Education Corporation. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01196169, a Phase 4 study, was terminated before completion, sponsored by Mountain Home Research & Education Corporation.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
Primary Outcome
Efficacy of daptomycin in preventing postoperative SSI will be determined for each enrolled subject on one month postoperative visit. Overall efficacy of daptomycin among the patient group who receive it will be compared to overall efficacy of vancomycin among the second patient group who receive vancomycin upon anticipated complete enrollment study at 24 months.
Interventions
- DRUG Vancomycin
- DRUG Daptomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
Why NCT01196169 stopped before completion
NCT01196169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.
NCT01196169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01196169 about?
NCT01196169 is a clinical study titled "Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty". This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) coloni...
What is the current status of trial NCT01196169?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2010-10. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01196169?
The interventions under investigation include: Vancomycin (DRUG), Daptomycin (DRUG).
Who is sponsoring clinical trial NCT01196169?
This trial is sponsored by Mountain Home Research & Education Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01196169's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 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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