Clinical Trial: Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia

Brief Summary: Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).

Detailed Summary: The optimal duration of the empirical antimicrobial therapy (AT) in hematological patients with febrile neutropenia (FN) is unknown. The Infectious Diseases Society of America (IDSA) recommends maintaining AT at least until the neutropenia is recovered, because literally "years of experience have proven this approach to be safe and effective". This recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by IDSA. The main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical AT in hematological patients with FN).
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Current Primary Outcome: Number of days on which patient is free of antimicrobial treatment [ Time Frame: 28 days following the initiation of empiric antibiotic treatment. ]

Protocol visits: Screening visit, Randomization visit, at 72h. of apyrexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit).


Original Primary Outcome: Number of days on which patient is free of antimicrobial treatment [ Time Frame: 28 days following the initiation of empiric antibiotic treatment. ]

Protocol visits: Screnning visit, Rarndomization visit, at 72h. of apirexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit).


Current Secondary Outcome:

  • Crude mortality [ Time Frame: 28 days following the initiation of empiric antibiotic treatment. ]
  • Number of days of fever [ Time Frame: 28 days following the initiation of empiric antibiotic treatment ]


Original Secondary Outcome: Same as current

Information By: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Dates:
Date Received: April 17, 2012
Date Started: April 2012
Date Completion:
Last Updated: June 16, 2016
Last Verified: June 2016