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Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant

NCT00324324 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2017-05-09

No results posted yet for this study

Summary

RATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.

PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.

Conditions

Interventions

DRUG

moxifloxacin hydrochloride

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

DRUG

Placebo

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Joseph Bubalo, PharmD, BCPS, BCOP · OHSU Knight Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-04-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00324324 on ClinicalTrials.gov