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

2016-12-05 17:23:21 | BioPortfolio

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.

Description

This is a national, multicenter, phase III, randomized, parallel arms, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of antibacterial prophylaxis - Levofloxacin 500mg/d given p.o.in newly diagnosed MDS patients who are more than 18 years of age and fulfil an indication for Azacytidine treatment. Patients will be treated for up to 4 cycles of Levofloxacin, or placebo. Subjects allocated to the treatment arm of the study will be administrated Levofloxacin 500mg/d given p.o. once a day, starting on day 10 from beginning of each cycle until day 28. Subject allocated to the placebo arm will be treated with placebo once a day, starting on day 10 from beginning of each cycle until day 28. Levofloxacin and placebo treatment will be continued in the first 4 Azacytidine cycles. This study consists of 3 periods for each study subject: pre-treatment period, treatment period and follow up period. Expected duration of subject participation is 6 months Pre-treatment period: Assessments: MDS evaluation by bone marrow examination including cytogenetics/ FISH must be performed within half a year of the first dose of study drug.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Prevention

Intervention

Levofloxacin

Location

Chim Sheba Medical Center
Tel Hashomer
Israel
52621

Status

Not yet recruiting

Source

Sheba Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-05T17:23:21-0500

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Medical and Biotech [MESH] Definitions

The L-isomer of Ofloxacin.

Specific practices for the prevention of disease or mental disorders in susceptible individuals or populations. These include HEALTH PROMOTION, including mental health; protective procedures, such as COMMUNICABLE DISEASE CONTROL; and monitoring and regulation of ENVIRONMENTAL POLLUTANTS. Primary prevention is to be distinguished from SECONDARY PREVENTION and TERTIARY PREVENTION.

The prevention of recurrences or exacerbations of a disease that already has been diagnosed. This also includes prevention of complications or after-effects of a drug or surgical procedure.

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A medical specialty primarily concerned with prevention of disease (PRIMARY PREVENTION) and the promotion and preservation of health in the individual.

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