BEATLE
Trial question
What is the effect of extended infusion of β-lactam antibiotics in patients with febrile neutropenia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 150
150 patients (79 female, 71 male).
Inclusion criteria: patients undergoing HSCT or with acute leukemia receiving chemotherapy who required empirical antibiotic treatment for febrile neutropenia.
Key exclusion criteria: allergy to the study drugs; systemic antibiotic therapy at febrile neutropenia onset; epilepsy or severe renal impairment; previous enrolment in the study without resolution of the first episode or enrolment five weeks before new febrile neutropenia episode.
Interventions
N=77 extended infusion (β-lactam antibiotics administered in half the time of dosing interval).
N=73 intermittent infusion (β-lactam antibiotics administered in 30 minutes).
Primary outcome
Treatment success at day 5
50.6%
63%
63.0 %
47.3 %
31.5 %
15.8 %
0.0 %
Extended
infusion
Intermittent
infusion
No significant
difference ↔
No significant difference in treatment success at day 5 (50.6% vs. 63%; ARD -12.4, 95% CI -29.4 to 4.7).
Secondary outcomes
No significant difference in death at day 30 (2.6% vs. 1.39%; AD 1.2%, 95% CI -4.46 to 6.88).
No significant difference in the rate of clinical resolution on day 5 (72% vs. 80%; ARD -8, 95% CI -23.2 to 7.2).
No significant difference in > 50% reduction of the maximum value of the CRP (50.7% vs. 54.3%; ARD -3.6, 95% CI -21.25 to 14.02).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients undergoing HSCT or with acute leukemia receiving chemotherapy who required empirical antibiotic treatment for febrile neutropenia, extended infusion was not superior to intermittent infusion with respect to treatment success at day 5.
Reference
Julia Laporte-Amargos, Francisco Carmona-Torre, Maria Huguet et al. Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients (BEATLE): a randomised, multicentre, open-label, superiority clinical trial. Clin Microbiol Infect. 2025 Feb;31(2):211-219.
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