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

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ClinicalTrials.gov Identifier: NCT00324324
Recruitment Status : Terminated
First Posted : May 11, 2006
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Bubalo, OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 10, 2006
First Posted Date  ICMJE May 11, 2006
Last Update Posted Date May 9, 2017
Study Start Date  ICMJE May 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2010)
Safety and tolerability [ Time Frame: 1 to 120 days post bone marrow transplant ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00324324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2010)
  • Incidence of bacteremia [ Time Frame: 1 to 120 days post bone marrow transplant ]
  • Incidence and severity of graft-versus-host disease [ Time Frame: 1 to 120 days post bone marrow transplant ]
  • Infection-related mortality [ Time Frame: 1 to 120 days post bone marrow transplant ]
  • Overall mortality [ Time Frame: 1 to 120 days post bone marrow transplant ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant
Official Title  ICMJE Randomized, Double Blinded, Placebo-Controlled Trial of Antibacterial Prophylaxis for the Prevention of Bacterial Infections in the Post-Engraftment Phase After Allogeneic Hematopoeitic Stem Cell Transplantation
Brief 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.

Detailed Description

OBJECTIVES:

Primary

  • Assess the safety and tolerability of giving prophylactic moxifloxacin hydrochloride during the post-engraftment phase in patients who have undergone allogeneic stem cell transplantation. (Pilot study)
  • Compare the efficacy, in terms of reducing the incidence of clinically and microbiologically documented bacterial infections, in patients who have undergone allogeneic stem cell transplantation treated with prophylactic moxifloxacin hydrochloride vs placebo during the post-engraftment phase. (Phase III)

Secondary

  • Determine the incidence of clinically and microbiologically documented bacterial infections in these patients. (Pilot study)
  • Assess the impact of moxifloxacin hydrochloride on the incidence of bacteremia in these patients. (Phase III)
  • Compare the percentage of time on systemic antibiotics and days hospitalized in patients treated with these regimens. (Phase III)
  • Compare the incidence of veno-occlusive disease of the liver in patients treated with these regimens. (Phase III)
  • Compare the incidence and severity of graft-versus-host disease in patients treated with these regimens. (Phase III)
  • Compare the infection-related mortality and overall mortality of patients treated with these regimens.

OUTLINE: This is a pilot study followed by a randomized, double-blind, placebo-controlled, multicenter phase III study. Patients are stratified according to gender and race (white vs. non-white). The first 20 patients are assigned to the pilot study.

Patients assigned to the pilot study receive oral moxifloxacin hydrochloride once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from allogeneic stem cell transplantation (ASCT) and continuing until day 100 post-transplantation in the absence of disease progression or unacceptable toxicity. Subsequent patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral moxifloxacin hydrochloride once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from ASCT and continuing until day 100 post-transplantation.
  • Arm II: Patients receive oral placebo once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from ASCT and continuing until day 100 post-transplantation.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at day 120 post-transplantation.

PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Infection
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Neuroblastoma
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: moxifloxacin hydrochloride
    Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
    Intervention: Drug: moxifloxacin hydrochloride
  • Placebo Comparator: Sugar pill
    Placebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue
    Intervention: Drug: Placebo
Publications * Bubalo JS, Leis JF, Curtin PT, et al.: A randomized, double-blinded, pilot trial of aprepitant added to standard antiemetics during conditioning therapy for hematopoietic stem cell transplant (HSCT). [Abstract] J Clin Oncol 25 (Suppl 18): A-9112, 520s, 2007.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
240
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Must be planning to undergo or have completed allogeneic stem cell transplantation (ASCT)

    • Must not be undergoing a nonmyeloablative ASCT
  • Must not require antibiotic prophylaxis against bacterial pathogens during the post-engraftment phase as per ASCT protocol
  • No known colonization with an antimicrobial-resistant organism normally sensitive to quinolones that is known to increase infection incidence (i.e., ciprofloxacin-resistant Pseudomonas not allowed; vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus aureus allowed)

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 100 days
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • No known hypersensitivity to fluoroquinolones
  • No prolonged QTc interval on EKG (i.e., QTc > 440 milliseconds)
  • No uncontrolled hypokalemia

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent class IA (e.g., quinidine or procainamide) or class III (e.g., amiodarone or sotalol) antiarrhythmics
  • No concurrent intravenous antibiotics for pre-enrollment infections except vancomycin, linezolid, dalfopristin, or quinupristin (Synercid®)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324324
Other Study ID Numbers  ICMJE CDR0000472877
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-TPI-02027-L ( Other Identifier: Oregon Health and Science University )
OHSU 0285 ( Other Identifier: Oregon Health & Science University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Bubalo, OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Joseph Bubalo, PharmD, BCPS, BCOP OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP