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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Completed; Phase 4

Conditions: Febrile Neutropenia

Treatments: Drug: Empirical antimicrobial treatment discontinuation; Drug: Standard empirical antimicrobial treatment discontinuation

Study type: Interventional

Funder types: Other

Identifiers

NCT01581333

2011-005152-34

Details and patient eligibility

About

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).

Full 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).

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Empirical antimicrobial treatment discontinuation

Treatment:

Drug: Empirical antimicrobial treatment discontinuation

Control Arm

Active Comparator group

Description:

Standard empirical antimicrobial treatment discontinuation

Treatment:

Drug: Standard empirical antimicrobial treatment discontinuation