NCT02981615

Phase 3 Multicenter Randomized Double Blind Placebo Controlled Study With Antibacterial Prophylaxis in Azacitidine Treated MDS Patients

A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Safety and Efficacy of Antibacterial Prophylaxis for Prevention of Infections in Azacitidine Treated Myelodysplastic Syndrome Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Infections are a major and prevalent life-threatening complication among patients with myelodysplastic syndrome (MDS). Currently, the role of prophylactic antibacterial agents after chemotherapy in MDS patients remains controversial and there are no clinical guidelines for infection prophylaxis in this clinical setting. We will conduct a prospective study to evaluate the potential benefit of prophylactic antibacterial (Levofloxacin) on the rate of febrile episodes/infections in Azacytidine treated MDS patients.

Detailed description

This is a national, multicenter, phase III, randomized, parallel arms, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of antibacterial prophylaxis - Levofloxacin 500mg/d given p.o.in newly diagnosed MDS patients who are more than 18 years of age and fulfil an indication for Azacytidine treatment. Patients will be treated for up to 4 cycles of Levofloxacin, or placebo. Subjects allocated to the treatment arm of the study will be administrated Levofloxacin 500mg/d given p.o. once a day, starting on day 10 from beginning of each cycle until day 28. Subject allocated to the placebo arm will be treated with placebo once a day, starting on day 10 from beginning of each cycle until day 28. Levofloxacin and placebo treatment will be continued in the first 4 Azacytidine cycles. This study consists of 3 periods for each study subject: pre-treatment period, treatment period and follow up period. Expected duration of subject participation is 6 months Pre-treatment period: Assessments: MDS evaluation by bone marrow examination including cytogenetics/ FISH must be performed within half a year of the first dose of study drug.

Conditions

• Prevention

Interventions

Type	Name	Description
DRUG	Levofloxacin	one tablet (500mg) a day, from day 10 to day 28 in every cycle of the 4 first cycles
DRUG	Placebo Oral Tablet	one tablet a day, from day 10 to day 28 in every cycle of the 4 first cycles

Timeline

• Start date: 2017-08-01
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2016-12-05
• Last updated: 2023-11-27

Locations

1 site across 1 country: Israel