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

May 7, 2017 updated by: Joseph Bubalo, OHSU Knight Cancer Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Knight Cancer Institute At Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: moxifloxacin hydrochloride
Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
Drug: moxifloxacin hydrochloride
Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
Placebo Comparator: Sugar pill
Placebo 1 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 1 to 120 days post bone marrow transplant
1 to 120 days post bone marrow transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of bacteremia
Time Frame: 1 to 120 days post bone marrow transplant
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
1 to 120 days post bone marrow transplant
Infection-related mortality
Time Frame: 1 to 120 days post bone marrow transplant
1 to 120 days post bone marrow transplant
Overall mortality
Time Frame: 1 to 120 days post bone marrow transplant
1 to 120 days post bone marrow transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Joseph Bubalo, PharmD, BCPS, BCOP, OHSU Knight Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 10, 2006

First Submitted That Met QC Criteria

May 10, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 7, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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