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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01581333

Acronym

HOWLONG

Enrollment

157

Registered

2012-04-20

Start date

2012-04-30

Completion date

2016-06-30

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia

Keywords

febrile neutropenia, antimicrobial treatment, procalcitonin

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 description

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).

Interventions

DRUGEmpirical 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.

DRUGStandard empirical antimicrobial treatment discontinuation

The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation. * Informed consent signed.

Exclusion criteria

* Fever with etiologic diagnosis. * Patients with epilepsy. * Pregnant or lactating women. * Patients with HIV infection. * Patients with severe renal failure.

Design outcomes

Primary

Measure	Time frame	Description
Number of days on which patient is free of antimicrobial treatment	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).

Secondary

Measure	Time frame	Description
Crude mortality	28 days following the initiation of empiric antibiotic treatment.	Number of died patients
Number of days of fever	28 days following the initiation of empiric antibiotic treatment	Number of days of fever

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026