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

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ClinicalTrials.gov Identifier: NCT01581333
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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).

Condition or disease Intervention/treatment Phase
Febrile Neutropenia Drug: Empirical antimicrobial treatment discontinuation Drug: Standard empirical antimicrobial treatment discontinuation Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia
Study Start Date : April 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Arm Intervention/treatment
Experimental: Experimental Arm
Empirical antimicrobial treatment discontinuation
Drug: 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.
Other Name: Clinical rules for finalization of antimicrobial therapy

Active Comparator: Control Arm
Standard empirical antimicrobial treatment discontinuation
Drug: Standard empirical antimicrobial treatment discontinuation

The empirical antimicrobial treatment discontinuation will occur when the patient is:

The neutrophil count is above 500 million per mm3.

Other Name: Laboratory rules for finalization of antimicrobial therapy




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Crude mortality [ Time Frame: 28 days following the initiation of empiric antibiotic treatment. ]
    Number of died patients

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581333


Locations
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Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain, 11407
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic
Barcelona, Spain, 08036
Bellvitge University Hospital
Barcelona, Spain, 08907
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37007
Virgen del Rocío University Hospital
Seville, Spain, 41013
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Study Director: José M Cisneros Herreros, PhD Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)
  Study Documents (Full-Text)

Documents provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Study Protocol and Informed Consent Form  [PDF] February 2, 2015


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01581333     History of Changes
Other Study ID Numbers: 2011-005152-34
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
febrile neutropenia
antimicrobial treatment
procalcitonin
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents