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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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