- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02527928
Cost-Effectiveness of Amphotericin B
Cost-Effectiveness of Different Formulation of Amphotericin B in Private and Public Hospitals in Southern Brazil
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND There are several American studies on the costs that the antifungal represents in the hospital bills, but in Brazil we do not have this type of study (WINGARD 2007; GREENE 2007). The American studies cannot be extrapolated to Brazil because the cost of drugs is different as well as other hospital charges. Furthermore, in Brazil spending on public medicine, governed by the Unified Health System (SUS) are different from those employed in the complementary health services (private health services). For these reasons, knowledge of the percentage they represent in the antifungal hospital bills in order to define the actual cost-effectiveness of different formulations of amphotericin B, considering length of hospital adverse events and mortality is needed.
OBJECTIVES:
Determine the direct and indirect hospital costs with different formulations of amphotericin B (deoxycholate, lipid complex and liposomal) in different public and private hospitals in the city of Curitiba, Paraná, Brazil.
Specifics
- Measuring the total cost of hospitalization with antifungal treatment.
- Measure the direct spending each formulation of amphotericin B
- Measuring the indirect costs related to the nephrotoxicity of different formulations of amphotericin B
- Assemble a model of cost-effectiveness of different formulations of amphotericin B
METHODS
This is a retrospective, observational, cohort study economic. Database of admissions of patients who used antifungal in all private hospital from an specific private health system (more than 5 hospitals) and databases of two large public hospitals in Curitiba (Evangelical University and the Clinical Hospital).
Patients over 18 years of age who used any formulation of amphotericin B will be included.
The data will be evaluated by the principal diagnosis ICD10 obtained at admission or discharge, the total length of stay, length of hospital stay before antifungal start, length of stay after initiation of antifungal drug, which formulation of amphotericin B used, the necessity and amount of dialysis. Also we will assess the final outcome of the patient (death or cure). Other epidemiological data such as age and gender will be evaluated.
A cost analysis will be based on total bill of the patient, the cost of antifungal, cost throughout the dialysis procedure, cost of laboratory tests used in monitoring during treatment with amphotericin (complete blood count, electrolytes, renal function, partial urine, function liver, electrocardiogram). The cost will be measured in American Dollar. These data were obtained from a similar study used for costing with antifungals in invasive aspergillosis in the USA (KIM 2011).
Data will be analyzed according to the type of variable. Means or medians will be used for continuous variables with standard deviation. Statistical methods for comparing means or medians will be parametric or non-parametric, as well as chi-square test for dichotomous variables. The data will be considered statistically significant when a difference of 5% (p <0.05) occur. Other multivariable method can be applied according with the results.
Informed consent is not necessary because is a retrospective cohort with data obtained from medical charts, without any intervention.
Principal investigator and co-investigator will be the sponsor for fill the request. All the survey will be fulfilled by investigator and co-investigator. The survey is attached in the end of the project.
This study will be sent for ethics committee for approval before start.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over 18 years of age who used any formulation of amphotericin B will be included
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
desoxycholate
Amphotericin B desoxicholate
|
|
Anfolipidcomplex
Amphotericin B complex lipid
|
|
ABLiposomal
Amphotericin B liposomal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost
Time Frame: Fungal infection at day 100
|
The outcome will measured in US dollar.
|
Fungal infection at day 100
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- teva
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Invasive Fungal Infections
-
Hospital Universitario La FeCompletedFungal Invasive DiseaseSpain
-
People's Hospital of Zhengzhou UniversityRecruitingFactors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly PatientsInvasive Fungal InfectionChina
-
Nantes University HospitalCompletedInvasive Fungal InfectionFrance
-
Mayo ClinicRecruitingCandidiasis | Fungal InfectionUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Melbourne HealthMerck Sharp & Dohme LLCRecruitingFungal Infection | Pharmacokinetics | Invasive Aspergillosis | Prophylaxis | Invasive Candidiases | Posaconazole | Invasive MycosisAustralia
-
Astellas Pharma Global Development, Inc.CompletedInvasive Fungal InfectionUnited States
-
Asan Medical CenterWithdrawnInvasive Fungal InfectionKorea, Republic of
-
Nanfang Hospital, Southern Medical UniversityNot yet recruiting
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.CompletedInvasive Fungal DiseaseChina
Clinical Trials on None intervention
-
University of Campania "Luigi Vanvitelli"CompletedBirth Weight | Systemic Inflammation Markers | Combined Systemic Inflammatory IndicesItaly
-
University of GiessenCompleted
-
Peking University First HospitalActive, not recruitingSARS-CoV-2 Infection | Hematologic MalignancyChina
-
Acibadem UniversityCompleted
-
Acibadem UniversityCompleted
-
Universidad Católica del MauleFondo Nacional de Desarrollo Científico y Tecnológico, ChileCompletedMental Disorders | Suicide, AttemptedChile
-
Shanghai Mental Health CenterUnknownSchizophrenia | ViolenceChina
-
Sir Run Run Shaw HospitalCompleted
-
Sir Run Run Shaw HospitalUnknown
-
Azienda Ospedaliero Universitaria Maggiore della...CompletedChronic Kidney Diseases