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Completed

NCT Number: NCT02906254

Early Antibiotic Discontinuation in FUO

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

About this study

Infections are responsible for significant morbidity and mortality in haematological patients, in particular during chemotherapy-induced neutropenia. Guidelines recommend immediate initiation of antibiotic therapy, whose optimal duration is unclear. The primary objective of this study is to evaluate early discontinuation of antibiotic treatment for Fever of Unknown Origin (FUO) in afebrile or febrile neutropenic patients. The secondary objective is to describe the epidemiology of febrile neutropenia (FN) in investigator centre.

Every episode of FN was prospectively identified. In the first phase of the study, empirical antibiotic therapy of FUO patients was stopped after 48 hours of apyrexia, in accordance with ECIL-4 (European Conference on Infections in Leukaemia) recommendations. In the second phase of the study, antibiotics were stopped on day 5 for all FUO patients, regardless of their temperature or their leukocyte count.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

ECIL-4 guidelines group

Other

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

Short-course antibiotic therapy

Other

Antibiotics were stopped on day 5 in febrile or afebrile patients

Primary outcomes

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

    Time frame: Month 1

    mortality, intensive care admissions, infection

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

    Time frame: Month 1

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

Secondary outcomes

  1. Epidemiology of febrile neutropenia

    Time frame: Month 1

    Clinical and biological data

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Early Discontinuation of Empirical Antibacterial Therapy in Febrile Neutropenia: Prospective Observational Study (ANTIBIOSTOP)

Acronym: ANTIBIOSTOP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2016
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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