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

NCT ID: NCT01581333

Last Updated: 2017-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-06-30

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).

Conditions

Febrile Neutropenia

Keywords

febrile neutropenia; antimicrobial treatment; procalcitonin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Empirical antimicrobial treatment discontinuation

Group Type: EXPERIMENTAL

Empirical antimicrobial treatment discontinuation

Intervention Type: DRUG

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.

Control Arm

Standard empirical antimicrobial treatment discontinuation

Group Type: ACTIVE_COMPARATOR

Standard empirical antimicrobial treatment discontinuation

Intervention Type: DRUG

The empirical antimicrobial treatment discontinuation will occur when the patient is:

The neutrophil count is above 500 million per mm3.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Clinical rules for finalization of antimicrobial therapy; Laboratory rules for finalization of antimicrobial therapy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José M Cisneros Herreros, PhD

Role: STUDY_DIRECTOR

Virgen del Rocío University Hospital/ Biomedicine Institute of Seville (IBIS)

Locations

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Clínic

Barcelona, , Spain

Bellvitge University Hospital

Barcelona, , Spain

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Virgen del Rocío University Hospital

Seville, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 29153975 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

2011-005152-34

Identifier Type: -

Identifier Source: org_study_id