Clinical trial NCT01581333: Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Febrile Neutropenia
Keywords: febrile neutropenia
antimicrobial treatment
procalcitonin
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Number of days on which patient is free of antimicrobial treatment
timeFrame: 28 days following the initiation of empiric antibiotic treatment.
Secondary outcomes:
measure: Crude mortality
timeFrame: 28 days following the initiation of empiric antibiotic treatment.
measure: Number of days of fever
timeFrame: 28 days following the initiation of empiric antibiotic treatment
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Seville
country: Spain
facility: Virgen del Rocío University Hospital
Study officials:
affiliation: Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)
name: José M Cisneros Herreros, PhD
role: STUDY_DIRECTOR
References:
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.