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NCT02981615

Phase 3 Multicenter Randomized Double Blind Placebo Controlled Study With Antibacterial Prophylaxis in Azacitidine Treated MDS Patients

Completed Phase 3 Last updated 27 November 2023
What this trial tests

Phase 3 trial testing Levofloxacin in Prevention in 67 participants. Completed in 30 July 2022.

Timeline
1 August 2017
Primary endpoint
30 July 2022
30 July 2022

Quick facts

Lead sponsorSheba Medical Center
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment67
Start date1 August 2017
Primary completion30 July 2022
Estimated completion30 July 2022
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Sheba Medical Center

Who can join

18 and older, any sex, with Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infections are a major and prevalent life-threatening complication among patients with myelodysplastic syndrome (MDS). Currently, the role of prophylactic antibacterial agents after chemotherapy in MDS patients remains controversial and there are no clinical guidelines for infection prophylaxis in this clinical setting. We will conduct a prospective study to evaluate the potential benefit of prophylactic antibacterial (Levofloxacin) on the rate of febrile episodes/infections in Azacytidine treated MDS patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Historical expectations with DNA methyltransferase inhibitor monotherapy in MDS: when is combination therapy truly "promising"?
    Brunner AM, Fell G, Steensma DP. · · 2022 · cited 3× · PMID 35143613 · DOI 10.1182/bloodadvances.2021006357

Verify or expand the search:

Other trials of Levofloxacin

Trials testing the same drug.

Other recruiting trials for Prevention

Currently open trials in the same condition.

Other Sheba Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02981615.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing