- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01581333
Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia (HOWLONG)
October 31, 2017 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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).
Study Overview
Status
Completed
Conditions
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).
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain, 08035
- Hospital Vall d'Hebron
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Barcelona, Spain, 08036
- Hospital Clínic
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Barcelona, Spain, 08907
- Bellvitge University Hospital
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Salamanca, Spain, 37007
- Hospital Clinico Universitario de Salamanca
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Seville, Spain, 41013
- Virgen del Rocio University Hospital
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Cádiz
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Jerez de la Frontera, Cádiz, Spain, 11407
- Hospital de Jerez
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Arm
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 Names:
|
Active Comparator: Control Arm
Standard empirical antimicrobial treatment discontinuation
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The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days on which patient is free of antimicrobial treatment
Time Frame: 28 days following the initiation of empiric antibiotic treatment.
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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).
|
28 days following the initiation of empiric antibiotic treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crude mortality
Time Frame: 28 days following the initiation of empiric antibiotic treatment.
|
Number of died patients
|
28 days following the initiation of empiric antibiotic treatment.
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Number of days of fever
Time Frame: 28 days following the initiation of empiric antibiotic treatment
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Number of days of fever
|
28 days following the initiation of empiric antibiotic treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: José M Cisneros Herreros, PhD, Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
April 17, 2012
First Submitted That Met QC Criteria
April 19, 2012
First Posted (Estimate)
April 20, 2012
Study Record Updates
Last Update Posted (Actual)
November 1, 2017
Last Update Submitted That Met QC Criteria
October 31, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-005152-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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