Active clinical trials for "Neutropenia"

Febrile neutropenia (FN) is a frequent and serious complication in patients with hematological malignancies undergoing intensive chemotherapy. The growth of antibiotic resistance is a major threat in high-risk neutropenic patients given that delay in introduction of appropriate empirical antibiotic therapy (EAT) in this population is associated with increased morbidity and mortality. In 2013, the 4th European Conference on Infections in Leukaemia (ECIL-4) group published new guidelines, promoting early adaptation of EAT in stable afebrile patients, regardless of neutrophil count and expected duration of neutropenia. Despite these evidence-based guidelines, discontinuation and de-escalation strategies are not widely implemented in hematology departments. However, recent studies have found that early adaptation of EAT is safe and feasible and could lead to reduced antibiotic consumption. In response to growing antibiotic resistance and low adherence to ECIL-4 guidelines in the hematology department in the center of Nice, the investigators have developed and implemented a multifaceted AMS intervention. This intervention aimed to improve the quality of febrile neutropenia management and to promote the adoption of early de-escalation and discontinuation strategies in high-risk neutropenic patients by our hematology team. The aim of this before-after study was to assess the impact of a multifaceted AMS intervention, promoting early adaptation of empirical antibiotic therapy, on antibiotic consumption and clinical outcomes in high-risk neutropenic patients. Secondly, the investigators sought to assess the applicability and adherence to de-escalation and discontinuation strategies by the hematology team. The primary endpoint was total antibiotic use during hospital stay, expressed as days of therapy (DOT). DOT was defined as the number of days that a patient received antibiotics regardless of the dose. Secondary endpoints included length of therapy (LOT), antibiotic-free days (AFD), 30-day mortality, ICU admission, Clostridium difficile infection and duration of stay. LOT was defined as the number of days that a patient received systemic antibiotic therapy, irrespective of the number of different antibiotics.

This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values, emergency calls and consultations for fever, and on hospitalizations for FN in children and adolescents with cancer to describe the frequency of episodes of FN, and of other clinically relevant FN-related measures to compare these frequencies and measures in reality vs. applying Bernese standard limits for defining fever (ear temperature ≥39.0°C) to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow) to determine if it would be useful to perform an interventional study on the question of different fever limits, powered to study both efficacy (frequency of FN) and safety (AE in delayed FN diagnosis) to use the platform of this prospective study to explore if the serum level of cortisol is associated with adverse events in FN HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°C to lower limits would increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint). increase the rate of other clinically important FN-related measures related to chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related measures during treatment of FN episodes diagnosed in reality (secondary endpoints 4,5,6). not relevantly decrease the proportion of FN with AE (secondary endpoint 7).

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

The purpose of this observational study is to examine the rate at which elevated body temperature (fever) is relieved by an itraconazole injection administrated to patients experiencing neutropenic fever . A neutropenic fever is an elevated body temperature that occurs at a time when the patient's white blood cell count is low. White blood cells aid the body's normal defenses against infection, so a fever during this period might make it difficult for the patient to fight infections.

This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects. PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.

The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with Candida, Aspergillus, and other opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an important step in the amelioration of fungal disease.

Study Hypothesis: EW02 is a polysaccharide-enriched crude extract from black soybean (BS). BS has been used extensively by the Chinese as food or traditional Chinese medicine for hundreds of years. It has been used as monotherapy to treat Diabetes, menorrhagia and leukorrhea. In combination with others, BS has been used to treat chemotherapy-induced leukopenia on more than 300 pts. The daily doses were 15g bid to 50g tid for 21 days. Side effects were generally mild, including epigastric discomfort, numbness, insomnia, and dry mouth. Recently BS was found to promote myelopoiesis and inhibit tumor growth through immunomodulation. In vitro assays showed BS-PS can stimulate production of cytokines and increase blood progenitors. In vivo studies also demonstrated that BS-PS can reduce neutropenia in mice received 5-FU by stimulating myeloid colony formation. We hypothesize that EW02 can reduce neutropenia in cancer patients who receive chemotherapy without side effects.

RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia. PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.