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Neutropenia clinical trials

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NCT ID: NCT04948463 Recruiting - Febrile Neutropenia Clinical Trials

Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia

ELSA-FN
Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

This randomised controlled trial will determine the non-inferiority of stopping empiric antibiotics prior to absolute neutrophil count (ANC) recovery (Early Stopping) versus stopping antibiotics upon ANC recovery (Standard of Care/ Late Stopping) , in children with cancer and high-risk febrile neutropenia (FN).

NCT ID: NCT04938206 Recruiting - Clinical trials for Neutropenia, Febrile

DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule

DISCERN-FN7
Start date: January 27, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04873765 Recruiting - Neutropenia Clinical Trials

Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

Start date: March 18, 2022
Phase: Phase 1
Study type: Interventional

This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.

NCT ID: NCT04758442 Recruiting - Clinical trials for Hematologic Malignancies

Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology

Hemato-Vanco
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Approximately 40 subjects meeting the inclusion and no exclusion criteria will be enrolled in the study. Vancomycin blood concentration will be measured at steady-state at three different moment for each participant : immediately before the infusion, 1 hour after the infusion and during the elimination phase (at 3, 4 or 5 hours after the infusion). This additional vancomycin serum concentration in the elimination phase will be used to estimate more precisely the vancomycin pharmacokinetic parameters in this specific population including the distribution volume and the elimination of the molecule. Ultimately, the purpose of this study is to create a nomogram to predict the optimal initial vancomycin dosing in adult patients with a hematologic cancer.

NCT ID: NCT04662892 Recruiting - Febrile Neutropenia Clinical Trials

An Analysis to Estimate Febrile Neutropenia (FN) in Patients Receiving Udenyca

POEM
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

This is a multicenter, prospective, observational cohort registry in subjects receiving myelosuppressive chemotherapy for a non-myeloid malignancy who are considered to be at high risk for developing febrile neutropenia (FN).

NCT ID: NCT04637464 Recruiting - Pediatric Cancer Clinical Trials

Early Termination of Empirical Antibiotics in Febrile Neutropenia in Children With Cancer

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04547829 Recruiting - Pediatric Cancer Clinical Trials

Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy

Start date: October 10, 2020
Phase: Phase 2
Study type: Interventional

The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.

NCT ID: NCT04497688 Recruiting - Clinical trials for Non Hodgkin's Lymphoma

Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.

NCT ID: NCT04460508 Recruiting - Lymphoma Clinical Trials

Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma

Start date: December 20, 2020
Phase: Phase 2
Study type: Interventional

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.

NCT ID: NCT04233996 Recruiting - Febrile Neutropenia Clinical Trials

Efficacy of Extended Infusion of β-lactam Antibiotics for the Treatment of Febrile Neutropenia in Hematologic Patients

BEATLE
Start date: June 5, 2019
Phase: Phase 4
Study type: Interventional

This study evaluates the administration of beta-lactam antibiotics in extended infusion in hematological patients with febrile neutropenia after 5 days of treatment. The beta-lactam antibiotics analyzed are the following: piperacillin-tazobactam, cefepime and meropenem. Half of patients will receive the antibiotic in intermittent infusion, while the other half will receive it in extended infusion.