View clinical trials related to Neutropenia, Febrile.
Filter by:The goal of this clinical trial is to compare a short course of antibiotics in patients in whom no bacterial infection is found with the current "golden standard": long-term antibiotic treatment in adult hematology patients who develop neutropenic fever. The main question it aims to answer is: whether the short-term treatment is equally safe for patients, hence the name 'SAFE study'. Participants will be randomly assigned (randomized) to one of two treatment options once they develop neutropenic fever: short-term or long-term antibiotic treatment. An additional blood sample, urine sample and stool sample will be collected. Researchers will compare the short-term and the long-term antibiotic treatment groups to see if the short treatment is equally safe as the long-term treatment group.
Febrile neutropenia (NF) is the leading cause of unscheduled hospitalization in children with cancer. Management classically involves emergency admission to hospital for intravenous antibiotic treatment until resolution of fever and neutropenia. However, children with NF are a heterogeneous group with varying risks of severe infection (10-29%). This approach, which is recognized as excessive for low-risk episodes of severe infection, particularly in terms of quality of life and cost, is no longer recommended. Management should move to a more personalized model that takes into account the individual probability of severe infection. Clinical decision rules (CDRs) have been proposed to facilitate risk stratification, but none are useful in our French population because of insufficient reproducibility or effectiveness.
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.
This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL) treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will prospectively collect clinical data and treatment outcome of patients with DLBCL who use prophylactic pegylated-filgrastim.