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

Febrile Neutropenia Clinical Trial

— HOWLONG  

Official title:

Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581333
• Other study ID #: 2011-005152-34
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2012
• Last updated: October 31, 2017
• Start date: April 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2017
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Bellvitge University Hospital	Barcelona
Spain	Hospital Clínic	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Virgen del Rocío University Hospital	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	28 days following the initiation of empiric antibiotic treatment.
Secondary	Crude mortality	Number of died patients	28 days following the initiation of empiric antibiotic treatment.
Secondary	Number of days of fever	Number of days of fever	28 days following the initiation of empiric antibiotic treatment