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Can a daily antibiotic stop deadly infections in blood cancer patients?

NCT ID NCT03594149

Disease control Sponsor: Centre Henri Becquerel Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the antibiotic levofloxacin can prevent fevers and infections in people with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) who are receiving the chemotherapy drug azacitidine. Infections are a major risk for these patients. The trial randomly assigned 60 participants to receive either levofloxacin or a placebo during their first three cycles of treatment, and tracked how many had a fever that required hospitalization and antibiotics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levofloxacin (an antibiotic)
What this could lead to
If it works, this could provide a simple way to reduce serious infections in people with MDS or AML during chemotherapy.
What could go wrong
This is a small, completed Phase 3 trial with only 60 participants. The antibiotic may not reduce fevers or could lead to antibiotic resistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Jul 2018

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Myelodysplastic syndromes

Contacts and locations

Locations

  • CHRU Lille

    Lille, 59037, France

  • CHU Amiens

    Amiens, 80000, France

  • CHU Caen

    Caen, 14033, France

  • Centre Henri Becquerel

    Rouen, 76000, France

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