NCT03594149

Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Henri Becquerel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Infections are a major life-threatening complication in patients with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Currently there is no guidelines about antibacterial prophylaxis to prevent infections in patients with myelodysplastic syndrome or acute myeloid leukaemia. The investigators will conduct a randomized prospective study to evaluate the benefit of prophylactic antibacterial by levofloxacin on febrile episode in Azacytidine treated patients (MDS and AML).

Detailed description

This is a randomized prospective study with 2 arms to evaluate the efficacy of Levofloxacin prophylaxis in Azacytidine treated patients (MDS and AML) Levofloxacin will be given 500mg/d p.o. for the first three cycles of Azacytidine in patients randomized in arm antibacterial prophylaxis. In control arm patients will not received levofloxacin. The expected duration of subject participation is one year after randomization.

Conditions

• Myelodysplastic Syndromes
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Levofloxacin	Levofloxacin 500 mg/d p.o.

Timeline

• Start date: 2018-07-18
• Primary completion: 2024-07-17
• Completion: 2024-12-29
• First posted: 2018-07-20
• Last updated: 2026-01-02

Locations

4 sites across 1 country: France