Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

All Conditions

Neoplasms

Mouth and Tooth Diseases

Symptoms and General Pathology

Acquired Immunodeficiency Syndrome

HIV Infections

Head and Neck Neoplasms

Candidiasis

Candidiasis, Oral

Mycoses

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Mouth Diseases

Stomatognathic Diseases

Frio Oral Rinse

Spencer W. Redding, DDS

The purpose of the study is to evaluate the efficacy of Iocide oral rinse as a treatment for Oral Candidiasis in any patient including but not limited to patients receiving radiation therapy or who have previously received radiation therapy for head and neck cancer, or patients positive for HIV/AIDS or are transplant patients.

A four-week study has been designed as an assessment of the clinical cure and mycological eradication of oral Candida isolates in 40 cancer patients referred by radiation oncologists during the course of his/her treatment. An estimated 35 patients will be evaluable at the end of the study. Candida infection is defined as positive clinical signs (white plaques) with positive potassium hydroxide (KOH) preparation and positive cultures. Colonization is defined as a positive culture without signs of clinical infection.

Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

Novel Rinse to Treat Oral Candidiasis in Cancer Patients "Evaluate Iocide Oral Rinse in Any Patient With Thrush, Including But Not Limited to Patients Currently Receiving or Post Radiation Therapy for Head and Neck Cancer or Patients Positive for HIV/AIDS or Transplant Patients"

National Institute of Dental and Craniofacial Research (NIDCR)

University of Texas

Biomedical Development Corporation

Spencer Redding, DDS, Med.

Blood and Lymph Conditions

Rare Diseases

Leukemia

Invasive Fungal Infections

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Aspergillosis

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a non-interventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.

Massimo Offidani, MD

Mario Delia, MD

Giorgina Specchia

Mario Delia

Nicola Vianelli

Rosa Fanci, MD

Rosa Fanci

Vincenzo Pavone

Annamaria Nosari, MD

Livio Pagano, MD

Morena Caira, MD

Mario Mancinelli, MD

Maria Grazia Garzia

Anna Chierichini

Adriano Venditti

Alessandro Busca

Chiara Cattaneo, MD

Chiara Cattaneo

Giuseppe Rossi

Adriana Vacca

Cristina Gasbarrino

Sergio Storti

Desiree Caselli

Elio Castagnola

Annunziata Manna

De Paolis

Mario Luppi

Luisa Verga

Marco Picardi, MD

Maria Enza Mitra

Cecilia Caramatti

Carlo Castagnola

Rosangela Invernizzi

Franco Aversa

Prassede Salutari

Bruno Martino

Alessandro Bonini

Lorella Melillo

Mareva Giacchino

Anna Candoni

Gianpaolo Nadali

Simone Cesaro

SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).

SEIFEM 2010:

EPIDEMIOLOGICAL SURVEY ON POSSIBLE PRE-HOSPITAL RISK FACTORS FOR DEVELOPING INVASIVE FUNGAL INFECTIONS IN PATIENTS AFFECTED BY ACUTE MYELOID LEUKEMIA

Background:

In two different multicenter surveys conducted in Italy from 1988-1997 and 1999-2003, (Invasive Fungal Infections) IFIs were found to be a frequent cause of morbidity and mortality in patients treated with conventional chemotherapies, particularly in those suffering from acute myeloid leukemia (AML).

In general, the major factors that have been recognized as influencing the likelihood of invasive fungal infection are the patient's immune status, the degree of any organ damage (e.g., mucositis), and overall microbial exposure (i.e., colonization, environment, and prior infection). Since the 1990s, different risk-stratification strategies have been evaluated in order to identify those patients who may benefit from intensive prophylactic and diagnostic measures. However, despite having similar risk profiles, only a subset of AML patients will develop an IFI. One of the most exciting recent advances in the understanding of the epidemiology of IFIs is the recognition of the complexity of the host and the identification of new host-related risk factors.

Aim of this study is to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors.

Aims and objective:

* To identify high risk subjects that can take advantage of an antifungal prophylaxis or an early antifungal treatment (preemptive treatment).
* To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).
* To analyze hospital-related sources of fungal infection, from well known predisposing factors (i.e. duration and severity of neutropenia) to other like central venous catheter, urinary catheter, comorbidities, etc.
* To analyze the impact of both the prophylactic regimen adopted and the antifungal treatment.

Design:

* Prospective, multicenter, observational and clinical-epidemiological study.
* The study is expected to enroll at least 500 patients with newly diagnosed acute myeloid leukemia, those eligible for treatment and those not eligible, within 2 years or until the achievement of a statistically evaluable number of cases.
* SEIFEM 2010 is a noninterventional registry and therefore there will not be any any change physicians' diagnostic and therapeutic choices, that remain related to local guidelines.
* Every patient who accept to take part to the study, will be asked to read and sign an informed consent.
* An apposite form, with a detailed epidemiological section, should be compiled by clinicians for each enrolled patient.
* A complete information page on the study is supplied to each patient enrolled.

Data collection:

In the questionnaire, possible risk factors for invasive fungal infections, prior to the onset of acute leukemia, are evaluated. The module consists of several sections:

* Personal information (age, sex, observation time of the case, AML subtype, performance status at admission), patient data will be anonymous.
* Comorbidities (diabetes, chronic renal failure, COPD, chronic liver disease, previous TBC)
* A section compiled by the patient about possible risk factors related to the daily living habits (location and type of residence, profession, hobbies, pets, personal hygiene, ambiental exposures, consume of tobacco, alcohol or illicit drugs and others)
* A second part of the form will be compiled at the time of evaluation after induction chemotherapy (between 30 and 40 days after chemotherapy) or, for those not suitable for conventional treatment, 30-40 days after diagnosis.

At the time of a diagnosis of fungal infection data on the type of infection, treatment and course of infection will be evaluated.

Eligibility:

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a noninterventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.

Participating centers:

Forty-three Italian divisions of Hematology will take part to the study, distributed among universities and highly specialized hospitals located throughout the country.

Pre-hospital Risk Factors for Invasive Fungal Infection

SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia

To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).

Catholic University of the Sacred Heart

Respiratory Tract (Lung and Bronchial) Diseases

Influenza, Human

Virus Diseases

Candidemia

Candidiasis, Invasive

Fungemia

Sepsis

Toxemia

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Senu Apewokin, MD

OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients

A Non-interventional Observational Study of Infectious Complications in Cancer Patients

To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients

To determine the overall incidence of different infections, including bacterial, fungal and viral infections in cancer patients receiving chemotherapy and / or hematopoietic stem cell transplantation.

* To describe the natural history of such infections in cancer patients.
* To monitor the adherence of Myeloma institute for research and therapy(MIRT) health care workers to the MIRT standard operational procedures (SOPs)
* To identify risk factors for the development of specific infections.
* To validate surrogate markers as early diagnostic tools for various infections.

University of Arkansas

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

Anti-Infective Agents

All Drugs and Chemicals

Clotrimazole

Miconazole

Fluconazole

Antifungal Agents

Posaconazole

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Antiprotozoal Agents

Antiparasitic Agents

risk predicted by genotyping two PTX3 single nucleotide polymorphisms (SNPs): homozygous for rs230561 and/or rs381652

risk predicted by genotyping two PTX3 single nucleotide polymorphisms (SNPs): other than homozygous for rs230561 and/or rs381652

Posaconazole is a triazole with broad-spectrum activity, to include Candida species, Aspergillus species, and other fungal pathogens, including the Zygomycetes. Posaconazole is available as slow release tablets (300mg/day) and as intravenous (IV) formulation (300mg/day) and is licensed and approved in Switzerland for the prevention of IFI, including mold and yeast infections, in patients \>18 years who are at high risk of developing these types of infection (patients with long-term neutropenia or HCT recipients). Furthermore, international guidelines recommend posaconazole for primary antifungal prophylaxis in high-risk patients, such as AML patients with prolonged neutropenia. Posaconazole is available in Switzerland under the name of Noxafil® in capsules of 100mg, suspension of 40mg/mL and intravenous formulation of 300mg/16.7 mL.

Fluconazole is an antifungal with activity against most Candida species. Fluconazole is licensed and approved in Switzerland for prophylaxis of IC in patients with neutropenia induced by chemotherapy or radiotherapy at a daily dose of 200 to 400 mg once daily. Fluconazole (200 mg or 400 mg once daily) is still currently used as primary antifungal prophylaxis (standard of care) in all 7 centers participating in this trial. Fluconazole is available in Switzerland under the name of Diflucan® in capsules of 50 mg, 150 mg and 200 mg and in powder for preparation of suspension (50 mg/5 ml and 200 mg/5 ml (forte)) or perfusion (2 mg/1 ml). Several generics of Diflucan® are authorized in Switzerland. Prescribing Diflucan® or any of its generics will remain at the discretion of and based on the standard operating procedures (SOP) at each institution.

Pierre-Yves Bochud, MD

Alexander Schauwvlieghe, MD PhD

Ine Moors, Dr

Johan Maertens, Prof

Christine Robin, Dr

Ludovic Cabanne, Mr

Anna Conen, MD PD

Nina Khanna, Prof

Véronique Erard, MD

Dionysios Neofytos, MD

This is a prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial to assess the efficacy of posaconazole-based antifungal prophylaxis allocation strategies for patients with acute myeloid leukemia who receive induction chemotherapy. Allocation strategy based on an invasive mold infection genetic risk will be double-blinded.

Background:

Invasive mold infections (IMI, grouping infections due to Aspergillus spp \[IA\] and non-Aspergillus mold) are a major concern in hematological patients, such as those with acute myeloid leukemia (AML) or myelodysplastic syndrome in transformation (MDSit), collectively named AML/MDSit in this protocol, or those undergoing hematopoietic cell transplantation (HCT), with incidence and mortality rates ranging between 3-15% and 25-45%, respectively. Primary antifungal prophylaxis has become the standard of care in such patients. Historically, fluconazole (inactive against IA) was used as prophylaxis and allowed for significant decrease in invasive candidiasis (IC). More recently, posaconazole (a broad-spectrum azole active against IA and other non-Aspergillus filamentous molds) was approved for primary antifungal prophylaxis in high-risk patient categories. However, universal prophylaxis with posaconazole has been challenged, based on the relatively low incidence of IMI and the large number of patients needed to treat. Moreover, administration of broad-spectrum azoles is costly and associated with a large number of complications. Hence, there is an urgent need to optimize antifungal prophylaxis by identifying those patients with the highest risk for IMI to receive a broad-spectrum azole. Pentraxin-3 (PTX3), a pattern recognition receptor, recognizes and binds to Aspergillus conidia, facilitates opsonization and subsequently leads to complement and phagocyte activation. Two single nucleotide polymorphisms (SNPs) in the gene encoding PTX3 have been identified as strong predictors for IA and/or IMI in human studies. What makes PTX3 SNPs different and important in clinical practice is: (i) the extent and reproducibility of basic science data with regards to PTX3 and IA, (ii) the validation of PTX3 SNPs associations with IA in many different patient populations, and (iii) the high frequency of minor allele in the general population. The investigators hypothesize that PTX3 SNPs could be used to identify patients at high risk for IMI, who will benefit the most from antifungal prophylaxis with broad-spectrum azoles.

Overall objective:

The overall aim of this project is to assess the effectiveness of the use of posaconazole-based antifungal prophylaxis in AML/MDSit patients in high risk group (single or double single homozygotes PTX-3 SNPs). Exploratory objectives are to assess the effectiveness of PTX3 SNPs testing to stratify the use of posaconazole-based antifungal prophylaxis in AML/MDSit patients according to low or high risk genotypes.

Methods:

Eligible patients will be tested by competitive allele-specific Polymerase Chain Reaction (PCR) from blood-extracted DNA samples for the presence of PTX3 SNPs rs230561 and rs3816527. Randomisation based on genetic testing will be performed at the latest 24h after the first neutropenia day (D0). Patients will be stratified based on genotyping results in two unbalanced strata: stratum A (high-risk PTX3 SNPs) to be randomized 1:1 posaconazole prophylaxis vs fluconazole and stratum-B (low-risk PTX3 SNPs) to be randomized 1:3 in favour of Fluconazole. Patients will be assessed for a diagnosis of possible, probable or proven Invasive Fungal Infections (IFI) based on consensus definition guidelines by the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) groups during 180 days after prophylaxis initiation.

Impact:

The results of this study may contribute to the optimization of primary antifungal prophylaxis, by preventing IMI while limiting the use of broad-spectrum azoles, thus decreasing complications and costs. This study is one of the first interventional clinical trials to use genetic factors for risk stratification in the field of hematology and infectious diseases, a concept frequently emphasized, however barely transcribed in practice, as precision medicine. Furthermore, the scope of the proposed study expands beyond the specific patient population. The results of this study could be used in the design and initiation of similar efforts in other high-risk patient categories, including allogeneic HCT and solid organ transplant (SOT) recipients.

prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial

The investigational medicinal products will be known by all roles but the arm allocation based on a genetic analysis will be blinded.

PTX3-targeted Antifungal Prophylaxis

PTX3 Genetically Stratified Randomized Double-blinded Allocation Event-driven Clinical Trial for Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia

The cumulative incidence of proven and probable invasive mold infection (IMI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) in the intention-to-treat (ITT) population by day 180.

The cumulative incidence of possible invasive mold infection (IMI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) by day 180 in the ITT population.

The cumulative incidence of probable and proven Invasive Fungal Infections (IFI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms), namely: (a) all IFI, (b) Invasive Aspergillosis (IA) only and (c) Invasive Candidiasis (IC) only in the ITT patient population by day 180.

The time to probable and proven invasive mold infection (IMI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) during 180 days in the ITT population

The cumulative incidence of mortality in the ITT population by day 180.

The time to use of amphotericin B/echinocandin in the ITT population during 180 days.

The number of patient-days of amphotericin B/echinocandin in the ITT population during 180 days.

The frequency/distribution of AE of interest in posaconazole and fluconazole treated participants in the ITT population during 180 days, namely:

1. Hepatotoxicity, defined by elevation of at least one of the following markers above \>5x upper limit of normal: transaminases, alkaline phosphatase and/or above \>3x upper limit of normal total bilirubin
2. New QTc prolongation, defined as QTc \>450 msec for men and \>470 msec for women

The cumulative incidence of probable and proven invasive fungal infections (IFI) (based on published consensus guidelines by the EORTC/MSG groups and after validation by an independent adjudication committee of infectious disease experts blinded to treatment arms) , namely: all Invasive Fungal Infections (IFI), all Invasive Mold Infections (IMI), Invasive Aspergillosis (IA) only and Invasive Candidiasis (IC) only in the per protocol (PP) population by day 180.

Swiss National Science Foundation

Bochud Pierre-Yves

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Rinse to Treat in Oral Candidiasis in Cancer Patients	NCT00612963	Candidiasis, Or... Thrush Candidiasis	Frio Oral Rinse	18 Years -	Biomedical Development Corporation
Pre-hospital Risk Factors for Invasive Fungal Infection	NCT01315925	Acute Myeloid L... Aspergillosis Candidiasis Mycoses		-	Catholic University of the Sacred Heart
Novel Rinse to Treat in Oral Candidiasis in Cancer Patients	NCT00612963	Candidiasis, Or... Thrush Candidiasis	Frio Oral Rinse	18 Years -	Biomedical Development Corporation
UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients	NCT01622595	Aspergillosis Candidemia C. Difficile		18 Years -	University of Arkansas
UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients	NCT01622595	Aspergillosis Candidemia C. Difficile		18 Years -	University of Arkansas
Pre-hospital Risk Factors for Invasive Fungal Infection	NCT01315925	Acute Myeloid L... Aspergillosis Candidiasis Mycoses		-	Catholic University of the Sacred Heart
PTX3-targeted Antifungal Prophylaxis	NCT03828773	Candidiasis Fungal Infectio... Acute Myeloid L... Genetic Predisp... Aspergillosis	Posaconazole Fluconazole	18 Years -	Centre Hospitalier Universitaire Vaudois

Spots Global Cancer Trial Database for candidiasis

Every month we try and update this database with for candidiasis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for candidiasis

Every month we try and update this database with for candidiasis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for candidiasis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.