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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01581333
First received: April 17, 2012
Last updated: June 16, 2016
Last verified: June 2016
  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
Other: Empirical antimicrobial treatment discontinuation
Other: Standard empirical antimicrobial treatment discontinuation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
  • Number of days of fever [ Time Frame: 28 days following the initiation of empiric antibiotic treatment ] [ Designated as safety issue: Yes ]

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
an individualized clinical protocol as the criterion to suspend the empirical antimicrobial therapy
Other: 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.
Active Comparator: Control Arm
the recovery of neutropenia (standard) as the criterion to suspend the empirical antimicrobian therapy.
Other: 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.


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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581333

Locations
Spain
Bellvitge University Hospital
L' Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain, 11407
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic
Barcelona, Spain, 08036
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)
  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 
Study First Received: April 17, 2012
Last Updated: June 16, 2016
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on August 23, 2016