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Neutropenia clinical trials

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NCT ID: NCT05061654 Withdrawn - Hematologic Cancer Clinical Trials

CEFtolozane-Tazobactam for the Empiric Anti-bacterial Treatment of Neutropenic Fever in Hematology Patients

CEF-10
Start date: August 2022
Phase: Phase 4
Study type: Interventional

Patients with blood cancers and those who received a bone marrow transplant frequently have low circulating white blood cell countS. Fever in patients with low white blood cell count requires early appropriate antibiotic treatment to prevent complications including death. Bacteria have increasingly become more resistant to existing antibiotic options. Ceftolozane-tazobactam is a newer type of antibiotic that has been shown to be safe and effective in infections caused by several types of resistant bacteria that can cause serious infections in individuals with low blood count. This study aims to examine the effectiveness of this antibiotic in these types of patients. Patients with blood cancer and those who have received a bone transplant will be offered the option to join this study if they develop unexplained fever. If informed consent is granted, they will receive ceftolozane-tazobactam on top of the usual care that such patients receive. The patients will then be followed very closely to check their response to the treatment and if they develop any untoward events. The study will include 164 patients over an estimated 2 year period. The study is funded by Merck & Co, the company that manufactures the study antibiotic. However, Merck & Co. will not be involved in the actual running of the study, the collection of the study results or their analysis and interpretation. The study protocol has been reviewed and approved by an independent research oversight committee.

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: NCT04930627 Not yet recruiting - Clinical trials for Glucose 6 Phosphatase Deficiency

Safety and Efficacy of Empagliflozin in GSD1b Patients With Neutropenia

EMPAtia
Start date: July 2021
Phase: Phase 2
Study type: Interventional

Treatment of neutropenia of Glycogenosis type 1b patients with empagliflozin

NCT ID: NCT04914702 Completed - Oncology Clinical Trials

Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.

Start date: September 16, 2021
Phase:
Study type: Observational

In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied. Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially. Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.

NCT ID: NCT04910698 Completed - Clinical trials for Acute Myeloid Leukemia

Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia

Start date: January 1, 2020
Phase:
Study type: Observational

There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.

NCT ID: NCT04904614 Active, not recruiting - Neutropenia Clinical Trials

Letermovir Use in Heart Transplant Recipients

Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

This is an open label trial in which letermovir will be given as prophylaxis for the prevention of CMV infection and disease to all heart transplants who are at risk for cytomegalovirus. The study will compare a 30 patient prospective cohort to a retrospective cohort of 374 heart transplant recipients for the rates of neutropenia. In addition, the tolerability of letermovir will be assessed in this population.

NCT ID: NCT04887831 Terminated - Bladder Cancer Clinical Trials

Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

PRESERVE3
Start date: June 4, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer.

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: NCT04844177 Not yet recruiting - Clinical trials for Severe Congenital Neutropenia

Total Lymphoid Irradiation Pre-HSCT in Severe Congenital Neutropenia

Start date: April 14, 2021
Phase: Phase 2
Study type: Interventional

Severe congenital neutropenia (SCN) is a group of primary immunodeficiencies caused by distinct gene mutations and characterized by neutrophil maturation impairment, which leads to neutropenia, predisposition to severe bacterial and fungal infections, and myeloid malignancies. Granulocyte-colony stimulation factor is used for pathogenetic therapy, however, no adequate response is seen in some patients. The only curative option for SCN is hematopoietic stem cell transplantation (HSCT). An indication for HSCT in SCN is: no adequate response to G-CSF therapy, or development of malignancies, or found unfavorable mutations of SCN genes, leading to poor response to G-CSF and high risk of malignant transformation. One of the major peculiarities of HSCT in SCN is a high risk of graft failure. That was described in few studies in SCN transplantation and was also observed in our SCN HSCT cohort. We also consider the role of TCRab/CD19 graft depletion, which is routinely used in our center for GVHD prophylaxis in increased risks of graft failure. Another problem often observed in our patients is the relatively high risks of death of infections, developed after graft failure. Due to predominantly early HSCT graft failure development, non-sufficient immuablation is presumed as the main reason for graft failure. Because of the low level of toxicity, associated with TCRab/CD19 depletion usage, this strategy is planned to be used in the current study. To increase an immunoablative potential of conditioning regimen in SCN, total lymphoid irradiation will be studied in combination with myeloablative agents and standardly used serotherapy.