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NCT01371656 · ClinicalTrials.gov registry record · Phase 3
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 624
- Enrollment target
NCT01371656: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT01371656 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 624 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01371656, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 624 participants
- Enrollment target
Study Summary
This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
Primary Outcome
A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.
Interventions
- DRUG levofloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 624 participants |
| Start Date | 2011-09 |
| Est. Completion | 2017-06 |
| Phase | Phase 3 |
What the finished NCT01371656 record still lists
NCT01371656 is an interventional study that assigns participants to a tested intervention. The registered 624 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 1 intervention - of which levofloxacin is the first listed.
NCT01371656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01371656 about?
NCT01371656 is a clinical study titled "Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation". This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemothe...
What is the current status of trial NCT01371656?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 624 participants. The study started on 2011-09. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01371656?
The interventions under investigation include: levofloxacin (DRUG).
Who is sponsoring clinical trial NCT01371656?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01371656's enrollment target sits among peer trials
624 587th of 2000 higher than 1,413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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