NCT01581333

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

4.1 years

First QC Date

April 17, 2012

Last Update Submit

October 31, 2017

Conditions

Febrile Neutropenia

Keywords

febrile neutropeniaantimicrobial treatmentprocalcitonin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Crude mortality

    28 days following the initiation of empiric antibiotic treatment.

  • Number of days of fever

    28 days following the initiation of empiric antibiotic treatment

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Empirical antimicrobial treatment discontinuation

Drug: Empirical antimicrobial treatment discontinuation

Control Arm

ACTIVE COMPARATOR

Standard empirical antimicrobial treatment discontinuation

Drug: Standard empirical antimicrobial treatment discontinuation

Interventions

Empirical antimicrobial treatment discontinuationDRUG

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.

Also known as: Clinical rules for finalization of antimicrobial therapy
Experimental Arm
Standard empirical antimicrobial treatment discontinuationDRUG

The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.

Also known as: Laboratory rules for finalization of antimicrobial therapy
Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic

Barcelona, 08036, Spain

Location

Bellvitge University Hospital

Barcelona, 08907, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Virgen del Rocío University Hospital

Seville, 41013, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29153975DERIVED

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • José M Cisneros Herreros, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 20, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

ES(6)