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

This study is currently recruiting participants.
Verified January 2013 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: January 3, 2013
Last verified: January 2013

April 17, 2012
January 3, 2013
April 2012
April 2014   (final data collection date for primary outcome measure)
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).
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: Screnning visit, Rarndomization 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).
Complete list of historical versions of study NCT01581333 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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).

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Febrile Neutropenia
  • 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.
  • 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.

  • Experimental: Experimental Arm
    an individualized clinical protocol as the criterion to suspend the empirical antimicrobial therapy
    Intervention: Other: Empirical antimicrobial treatment discontinuation
  • Active Comparator: Control Arm
    the recovery of neutropenia (standard) as the criterion to suspend the empirical antimicrobian therapy.
    Intervention: Other: Standard empirical antimicrobial treatment discontinuation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
156
December 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Clara M Rosso Fernández, MD 0034955013414 claram.rosso.sspa@juntadeandalucia.es
Spain
 
NCT01581333
2011-005152-34
No
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Not Provided
Study Director: José M Cisneros Herreros, PhD Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP