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

Phase 4

Completed

• Conditions: Febrile Neutropenia
• Interventions: Drug: Empirical antimicrobial treatment discontinuation; Drug: Standard empirical antimicrobial treatment discontinuation

• Registration Number: NCT01581333
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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).

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

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Exclusion Criteria

• Fever with etiologic diagnosis.
• Patients with epilepsy.
• Pregnant or lactating women.
• Patients with HIV infection.
• Patients with severe renal failure.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Empirical antimicrobial treatment discontinuation	Empirical antimicrobial treatment discontinuation
Control Arm	Standard empirical antimicrobial treatment discontinuation	Standard empirical antimicrobial treatment discontinuation

Primary Outcome Measures

Name	Time	Method
Number of days on which patient is free of antimicrobial treatment	28 days following the initiation of empiric antibiotic 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).

Secondary Outcome Measures

Name	Time	Method
Crude mortality	28 days following the initiation of empiric antibiotic treatment.	Number of died patients
Number of days of fever	28 days following the initiation of empiric antibiotic treatment	Number of days of fever

Trial Locations

Locations (6)

Hospital de Jerez; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Bellvitge University Hospital; 🇪🇸 Barcelona, Spain

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Virgen del Rocío University Hospital; 🇪🇸 Seville, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain