A Phase 4 interventional study of Empirical antimicrobial treatment discontinuation and Standard empirical antimicrobial treatment discontinuation in Febrile Neutropenia, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Completed at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-01.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Phase 4, Interventional, and Other
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).
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).
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's enrollment of 157 is above the median of 93 across 276 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Empirical antimicrobial treatment discontinuation
Drug: Empirical antimicrobial treatment discontinuation
Standard empirical antimicrobial treatment discontinuation
Drug: Standard empirical antimicrobial treatment discontinuation
Empirical antimicrobial treatment discontinuation will occur when the patient is: Afebrile, with resolution of signs, symptoms and test abnormalities secondary to complementary source of infection and with normalization of vital signs for ≥ 72 h.
Also known as: Clinical rules for finalization of antimicrobial therapy
The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.
Also known as: Laboratory rules for finalization of antimicrobial therapy
Number of days on which patient is free of antimicrobial 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).
Time frame: 28 days following the initiation of empiric antibiotic treatment.
Crude mortality
Number of died patients
Time frame: 28 days following the initiation of empiric antibiotic treatment.
Number of days of fever
Number of days of fever
Time frame: 28 days following the initiation of empiric antibiotic treatment
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla