drugset / Trial / NCT02981615

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

NCT02981615

Phase 3 Completed 67 enrolled Sheba Medical Center
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2017-08-01
Primary completion
2022-07-30
Completion
2022-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Levofloxacin Small molecule 500 mg Oral

Indications

No indication recorded.