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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Tran

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 Summary:

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
Sponsor: OHSU Knight Cancer Institute

Current Primary Outcome: Safety and tolerability [ Time Frame: 1 to 120 days post bone marrow transplant ]

Original Primary Outcome:

Current Secondary Outcome:

  • 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:

Information By: OHSU Knight Cancer Institute

Dates:
Date Received: May 10, 2006
Date Started: May 2006
Date Completion:
Last Updated: May 7, 2017
Last Verified: May 2017