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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581333
First Posted: April 20, 2012
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  Purpose
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 Intervention Phase
Febrile Neutropenia Drug: Empirical antimicrobial treatment discontinuation Drug: Standard empirical antimicrobial treatment discontinuation Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

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

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


Enrollment: 157
Study Start Date: April 2012
Study Completion Date: June 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
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
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] October 20, 2017

  More Information

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 Submitted: April 17, 2012
First Posted: April 20, 2012
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:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Infective Agents
Anti-Bacterial Agents