Myelodysplastic SyndromesPhase 3AZABACNCT03594149
Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients
A Phase 3 study testing Levofloxacin in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Centre Henri Becquerel at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia
- What is being tested?
- Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Jul 2018to 29 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Amiens
Amiens, 80000
CHU Caen
Caen, 14033
CHRU Lille
Lille, 59037
Centre Henri Becquerel
Rouen, 76000
About this study
Official title: Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
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).
Read the 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
- Being tested
- Levofloxacin
- Keywords
- levofloxacin, antibacterial prophylaxis, febrile episode
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called LVF
Levofloxacin 500 mg/d p.o.
| Study group | Role | What they receive |
|---|---|---|
| antibacterial prophylaxis | Experimental | Levofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine Receives: Drug: Levofloxacin |
| control | No intervention | No levofloxacin will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Febrile episode occurrence
Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation
Measured: 3 cycles of 28 days
Secondary outcomes (8)
one-year overall survival rate
overall survival at one year in both two arms
Measured: one year
infectious agents documented in each arm
index of infectious agents in both two arms
Measured: one year
infectious events rate
number of infectious events in both two arms
Measured: one year
apparition of multi-drug resistant bacteria
index of multi-drug resistant bacteria in both two arms
Measured: one year
duration of hospitalization
number of days of hospitalization and number of days of antibiotic or antifungal treatment
Measured: one year
carbapenem and glycopeptide consumption in both two arms
consumption of carbapenem and glycopeptide during inclusion period and comparison with the 3 previous years
Measured: 3 years
death causes
index of death causes in each arms
Measured: one year
toxicity profile (adverse event)
toxicity will be established with description of adverse event in both two arms
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start18 Jul 2018
- Primary completion17 Jul 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stamatoullas-Bastard Aspasia, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594149
- Sponsor's protocol ID
- CHB 17.01
- Acronym
- AZABAC
- Status last verified
- Dec 2025
- First submitted
- 10 Jul 2018
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients
- ClinicalTrials.gov ID
- NCT03594149
- Acronym / sponsor ID
- AZABAC / CHB 17.01
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia
- Keywords
- levofloxacin, antibacterial prophylaxis, febrile episode
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibacterial prophylaxis | Experimental | Drug: LevofloxacinLevofloxacin 500 mg/d p.o. during the first 3 cycles of azacytidine |
| control | No intervention | –No levofloxacin will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- allergy to quinolone
- previous event of tendopathy due to quinolone
- previous epileptic event
- systemic antibacterial prophylaxis the month before enrolment
- HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinAlso: LVFLevofloxacin 500 mg/d p.o. | Drug | antibacterial prophylaxis |
Primary outcome
Febrile episode occurrence
Time frame: 3 cycles of 28 days
Febrile episode occurrence during the3 first cycles of azacytidine requiring hospitalization and introduction of an antibiotic (with or without levofloxacin discontinuation
8 secondary outcomes
one-year overall survival rate
Time frame: one year
infectious agents documented in each arm
Time frame: one year
infectious events rate
Time frame: one year
apparition of multi-drug resistant bacteria
Time frame: one year
duration of hospitalization
Time frame: one year
carbapenem and glycopeptide consumption in both two arms
Time frame: 3 years
death causes
Time frame: one year
toxicity profile (adverse event)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stamatoullas-Bastard Aspasia, MD principal investigator
Centre Henri Becquerel
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin in people with Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Centre Henri Becquerel at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Febrile episode occurrence (time frame: 3 cycles of 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.