CompletedPhase 3

Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

France60 participantsStarted 2018-07-18

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Febrile episode occurrence

Timeframe: 3 cycles of 28 days

Trial details

NCT IDNCT03594149

SponsorCentre Henri Becquerel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-17

View on ClinicalTrials.gov More Myelodysplastic Syndromes trials