Clinical trial · Interventional
Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients
Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levofloxacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- antibacterial prophylaxis
- description
- Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine
- interventionNames
- Drug: Levofloxacin
- type
- NO_INTERVENTION
- label
- control
- description
- No levofloxacin will be given.
Primary outcomes (1)
- measure
- Febrile episode occurrence
- timeFrame
- 3 cycles of 28 days
- description
- Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age superior to 18 years old * SMD or AML treated with azacytidine (not previously treated) * Life expectancy more than 3 months * Performance status inferior to 3 * signed inform consent Exclusion Criteria: * allergy to quinolone * previous event of tendopathy due to quinolone * previous epileptic event * systemic antibacterial prophylaxis the month before enrolment * HIV positive * bacterious infection of indetermined fever * participation to an investigational drug trial * Abnormalities in hepatic assessment * QTc superior to 450 ms * Pregnant or lactating women * Myasthenia * G6PD deficient * severe and uncontrolled diabetes * patient not able to understand trial
References
Publications (0)
Data not yet available