Early Termination of Empirical Antibiotics in High-risk Febrile Neutropenia in Children With Cancer: an Open-label, Randomised, Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study is a nationwide, multicenter, open label, randomized controlled trial. A target population of 220 children in treatment for cancer with neutropenic fever and a neutrophil count below 0.5 × 10⁹ cells/L with expected duration for more than 7 days will be recruited during the first 48 hours of antibiotic treatment (24 months inclusion period). They will be randomized 1:1 as follows: Experimental group: Discontinuation of antibiotics, despite neutrophil count below 0.5 × 10⁹ cells/L, after 48 hours of apyrexia and clinical stability Control group: Discontinuation of antibiotics when neutrophil count is equal to or above 0.5 × 10⁹ cells/L and the child is afebrile and clinically stable (up to maximum of 14 days after apyrexia and clinical stability). Primary endpoint is the number of days without antibiotic treatment in 28 days after treatment initiation. Secondary endpoints are crude mortality, severe adverse events, days with relapsing fever, and alterations of the microbiome.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: No
View:

• patient with cancer aged 18 years or below,

• absolute neutrophil count below 0.5x10⁹/L with expected duration of neutropenia for more than 7 days, and

• a single temperature of at least 38.5°C, or a temperature above 38.0°C sustained over a 1-hour period (auricular, oral or rectal).

Locations
Other Locations
Denmark
Aarhus University Hospital Skejby
Not yet recruiting
Aarhus
Rigshospitalet
Recruiting
Copenhagen
Odense Univesity Hospital
Not yet recruiting
Odense
Contact Information
Primary
Nadja Vissing, MD, PhD
nadja.hawwa.vissing@regionh.dk
+4535451312
Backup
Ulrikka Nygaard, MD, PhD
ulrikka.nygaard@regionh.dk
+4535459761
Time Frame
Start Date: November 20, 2020
Estimated Completion Date: September 1, 2023
Participants
Target number of participants: 220
Treatments
Experimental: Experimental group
Discontinuation of empirical antibiotics, despite neutrophil count below 0.5x10⁹ cells/L, after 48 hours of apyrexia and clinical stability.~A child is considered clinically stable when there is resolution of all symptoms and signs of infection, and normalization of vital signs including heart rate, respiratory rate, oxygen saturation, blood pressure, and daily diuresis.
No Intervention: Control group
Discontinuation of antibiotics when neutrophil count is equal to or above 0.5x10⁹ cells/L, and the child is afebrile and clinical stable OR the child has received 10 days of antibiotics and have been afebrile and clinically stable for 7 days
Sponsors
Leads: Kjeld Schmiegelow

This content was sourced from clinicaltrials.gov

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