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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Safety and tolerability
1 to 120 days post bone marrow transplant
Yes
Joseph Bubalo, PharmD, BCPS, BCOP
Principal Investigator
OHSU Knight Cancer Institute
United States: Food and Drug Administration
CDR0000472877
NCT00324324
May 2006
December 2012
Name | Location |
---|---|
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |