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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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: February 3, 2014
Last verified: February 2014
  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 apirexy (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 ]

Estimated Enrollment: 156
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (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
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.
  • Patients who have received allogeneic hematopoietic cell transplantation.
  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

Contacts
Contact: Clara M Rosso Fernández, MD 0034955013414 claram.rosso.sspa@juntadeandalucia.es

Locations
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Pere Barba Suñol, MD         
Sub-Investigator: Isabel Ruiz, MD         
Sub-Investigator: Nerea Castillo Flores, MD         
Sub-Investigator: David Valcárcel Ferreiras, MD         
Hospital Clínic Recruiting
Barcelona, Spain, 08036
Principal Investigator: Montserrat Rovira Tarrats, MD         
Hospital Clínico Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Principal Investigator: Lourdes Vázquez López, MD         
Sub-Investigator: Lucía López Corral, MD         
Sub-Investigator: María D. Caballero Barrigón, MD         
Virgen del Rocío University Hospital Recruiting
Seville, Spain, 41013
Principal Investigator: José M. Cisneros Herreros, PhD         
Sub-Investigator: Ildefonso Espigado Tocino, MD         
Sub-Investigator: Rocío Parody Porras, MD         
Sub-Investigator: José González Campos, MD         
Sub-Investigator: José Falantes González, MD         
Sub-Investigator: Manuela Aguilar Guisado, MD         
Sub-Investigator: José Molina Gil-Bermejo, MD         
Sub-Investigator: Inmaculada Domínguez Pascual         
Sub-Investigator: Clara M Rosso Fernández, MD         
Sub-Investigator: Maria Almudena Martin Peña         
Sub-Investigator: Isabel Montero Cuadrado         
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

No publications provided

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: February 3, 2014
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:
Fever
Neutropenia
Febrile Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014