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:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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
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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
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 | Not yet 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 | Active, not recruiting |
| Barcelona, Spain, 08036 | |
| Hospital Clínico Universitario de Salamanca | Not yet 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 | |
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: | January 3, 2013 |
| 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 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 May 19, 2013