NCT03594149CompletedPhase 3
Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients
Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 10 Jul 2018
- Start date
- 18 Jul 2018
- Primary completion date
- 17 Jul 2024
- Lead sponsor
- Centre Henri Becquerel
- NCT number
- NCT03594149
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 60
- From 18 Jul 2018 to the primary completion date, 17 Jul 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous event of tendopathy due to quinolone
- previous epileptic event
- systemic antibacterial prophylaxis the month before enrolment
- participation to an investigational drug trial
Other illness
- allergy to quinolone
- HIV positive
- bacterious infection of indetermined fever
- severe and uncontrolled diabetes
Lab values
- QTc superior to 450 ms
Other
- Abnormalities in hepatic assessment
- Pregnant or lactating women
- Myasthenia
- G6PD deficient
- patient not able to understand trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.