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

NCT02981615 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-11-27

No results posted yet for this study

Summary

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.

Conditions

  • Prevention

Interventions

DRUG

Levofloxacin

one tablet (500mg) a day, from day 10 to day 28 in every cycle of the 4 first cycles

DRUG

Placebo Oral Tablet

one tablet a day, from day 10 to day 28 in every cycle of the 4 first cycles

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Drorit G Merkel, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-07-30
Completion
2022-07-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981615 on ClinicalTrials.gov