Early Antibiotic Discontinuation in FUO

NCT02906254 | Completed

• 1 other identifier: ANTIBIOSTOP
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be responsible for side-effects and selection of resistance. This study demonstrates the safety of an early discontinuation of empirical treatments, in carefully selected patients presenting with fever of unknown origin.

Conditions

Febrile Neutropenia; Hematological Malignancy

Outcome Measures

Primary Outcomes (2)

• Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count.

  mortality, intensive care admissions, infection

  Month 1

• tolerability of a short-term antibiotic treatment in afebrile or febrile

  Duration of antibiotic therapy (days), duration of fever (days)

  Month 1

Secondary Outcomes (1)

• Epidemiology of febrile neutropenia

  Month 1

Study Arms (2)

ECIL-4 guidelines group

For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia: \- From 1st February 2014 to 30th November 2014, antibiotics were stopped when patients had been afebrile for more than 48 hours, as recommended by the ECIL-4 guidelines

Other: ECIL-4 guidelines group

short-course antibiotic therapy

For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia: \- From 1st December 2014 to 30th September 2015, antibiotics were stopped on day 5 in febrile or afebrile patients (short-course antibiotic therapy).

Other: ECIL-4 guidelines group; Other: Short-course antibiotic therapy

Interventions

ECIL-4 guidelines group OTHER

Antibiotics were stopped when patients had been afebrile for more than 48 hours

ECIL-4 guidelines group; short-course antibiotic therapy

Short-course antibiotic therapy OTHER

Antibiotics were stopped on day 5 in febrile or afebrile patients

short-course antibiotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient admitted to the Department of Clinical Haematology of Brest Teaching Hospital (France) was eligible for this study.

You may qualify if:

• age ≥ 18 years;
• presence of a malignant haematological disease combined with chemotherapy-induced neutropenia (polymorphonuclear neutrophil (PMN) count ≤ 500/mm3)
• fever defined by tympanic temperature of ≥38°C for ≥1 hour or a single temperature of ≥38.3°C

You may not qualify if:

• Patients without curative care
• chronic neutropenia (PMN≤ 500/mm3 for 3 months or more)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Febrile Neutropenia; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms

Study Officials

• Gaelle Guillerm, MD

  Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France

  PRINCIPAL INVESTIGATOR

• Jean-Philippe Talarmin, MD

  Department of Internal Medicine, Infectious Diseases and Hematology, Cornouaille Hospital Quimper, Avenue Yves Thépot, 29000 Quimper, France

  PRINCIPAL INVESTIGATOR

• Lenaïg Le Clech, MD

  Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 20, 2016
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

FR (1)