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

Primary Purpose

Febrile Neutropenia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Empirical antimicrobial treatment discontinuation
Standard empirical antimicrobial treatment discontinuation
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Febrile Neutropenia focused on measuring febrile neutropenia, antimicrobial treatment, procalcitonin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Jerez
  • Hospital Vall d'Hebron
  • Hospital Clínic
  • Bellvitge University Hospital
  • Hospital Clínico Universitario de Salamanca
  • Virgen del Rocío University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm

Control Arm

Arm Description

Empirical antimicrobial treatment discontinuation

Standard empirical antimicrobial treatment discontinuation

Outcomes

Primary Outcome Measures

Number of days on which patient is free of antimicrobial 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
Number of died patients
Number of days of fever
Number of days of fever

Full Information

First Posted
April 17, 2012
Last Updated
October 31, 2017
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT01581333
Brief Title
Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia
Acronym
HOWLONG
Official Title
Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia
Keywords
febrile neutropenia, antimicrobial treatment, procalcitonin

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Empirical antimicrobial treatment discontinuation
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Standard empirical antimicrobial treatment discontinuation
Intervention Type
Drug
Intervention Name(s)
Empirical antimicrobial treatment discontinuation
Other Intervention Name(s)
Clinical rules for finalization of antimicrobial therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard empirical antimicrobial treatment discontinuation
Other Intervention Name(s)
Laboratory rules for finalization of antimicrobial therapy
Intervention Description
The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.
Primary Outcome Measure Information:
Title
Number of days on which patient is free of antimicrobial treatment
Description
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).
Time Frame
28 days following the initiation of empiric antibiotic treatment.
Secondary Outcome Measure Information:
Title
Crude mortality
Description
Number of died patients
Time Frame
28 days following the initiation of empiric antibiotic treatment.
Title
Number of days of fever
Description
Number of days of fever
Time Frame
28 days following the initiation of empiric antibiotic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José M Cisneros Herreros, PhD
Organizational Affiliation
Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Bellvitge University Hospital
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Virgen del Rocío University Hospital
City
Seville
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29153975
Citation
Aguilar-Guisado M, Espigado I, Martin-Pena A, Gudiol C, Royo-Cebrecos C, Falantes J, Vazquez-Lopez L, Montero MI, Rosso-Fernandez C, de la Luz Martino M, Parody R, Gonzalez-Campos J, Garzon-Lopez S, Calderon-Cabrera C, Barba P, Rodriguez N, Rovira M, Montero-Mateos E, Carratala J, Perez-Simon JA, Cisneros JM. Optimisation of empirical antimicrobial therapy in patients with haematological malignancies and febrile neutropenia (How Long study): an open-label, randomised, controlled phase 4 trial. Lancet Haematol. 2017 Dec;4(12):e573-e583. doi: 10.1016/S2352-3026(17)30211-9. Epub 2017 Nov 15.
Results Reference
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Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia

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