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NCT00138112 · ClinicalTrials.gov registry record · Phase 3
Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation
A Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
NCT00138112: Completed Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00138112 is a Phase 3 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 126 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00138112, a Phase 3 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
Study Summary
This is a randomized 2-arm study to compare two different times of giving the drug vancomycin. Half of the patients will begin vancomycin two days before a bone marrow transplant. The other half will get it as soon as they have the first fever. Streptococci are bacteria that live in one's mouth and gut. These bacteria can escape into the blood when the lining of the mouth and gut weakens from cancer therapy. This can make the person who is undergoing a bone marrow transplant very sick. All patients who get this infection are treated with antibiotics. Vancomycin is one drug that is used to treat this bloodstream infection once it is diagnosed. Studies have shown that giving vancomycin before a bone marrow transplant seems to prevent this infection. However, giving vancomycin too soon may increase the chance that the kidneys will be irritated. It may also increase the chance that other bacteria will become resistant to this drug. We, the investigators at Memorial Sloan-Kettering Cancer Center, do not know if waiting to start vancomycin until the patient has a first fever can also prevent this infection.
Interventions
- DRUG Empirical Vancomycin
- DRUG Prophylactic Vancomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2003-11 |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138112
The ClinicalTrials.gov registry entry for NCT00138112 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Empirical Vancomycin is the first listed.
NCT00138112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00138112 about?
NCT00138112 is a clinical study titled "Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation". This is a randomized 2-arm study to compare two different times of giving the drug vancomycin. Half of the patients will begin vancomycin two days before a bone marrow transplant. The other half will get it as soon as they have the first fever. Streptococci are bacteria that live in one's mouth and...
What is the current status of trial NCT00138112?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2003-11. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00138112?
The interventions under investigation include: Empirical Vancomycin (DRUG), Prophylactic Vancomycin (DRUG).
Who is sponsoring clinical trial NCT00138112?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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