NCT02527928

Brief Summary

Invasive fungal infections (IFIs) are complications that happen in the hospital, usually in patients hospitalized for long periods in intensive care units (ICU) after invasive procedures, and in specific populations, such as cancer patients. The aim of this study is to 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

March 20, 2015

Last Update Submit

August 17, 2015

Conditions

Invasive Fungal Infections

Keywords

pharmacoeconomics

Outcome Measures

Primary Outcomes (1)

  • Cost

    The outcome will measured in US dollar.

    Fungal infection at day 100

Study Arms (3)

desoxycholate

Amphotericin B desoxicholate

Other: None intervention

Anfolipidcomplex

Amphotericin B complex lipid

ABLiposomal

Amphotericin B liposomal

Interventions

None interventionOTHER
desoxycholate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a study of pharmacoeconomics. Patients who used amphotericin B e total cost of hospitalization.

You may qualify if:

  • Patients over 18 years of age who used any formulation of amphotericin B will be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 20, 2015

First Posted

August 19, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

August 19, 2015

Record last verified: 2015-08