PEACE: Pediatric Antifungal Comparative Effectiveness
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | Any - 18 |
Updated: | 5/26/2018 |
Start Date: | January 2015 |
End Date: | April 2018 |
International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis
The overarching objective is to develop new evidence-based treatment guidelines for invasive
fungal diseases in children. To accomplish that, this protocol will focus on two specific
aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole
antifungal therapy for pediatric invasive candidiasis and for the subset of patients with
invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive
candidiasis per hospital admissions.
fungal diseases in children. To accomplish that, this protocol will focus on two specific
aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole
antifungal therapy for pediatric invasive candidiasis and for the subset of patients with
invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive
candidiasis per hospital admissions.
This study is a multicenter, national and international, prospective observational
comparative effectiveness study.
The primary aim of this study is to compare the effectiveness of echinocandin versus
amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for
invasive candidemia. The primary effectiveness endpoint for study aim 1 is the comparison of
global response at 14 days of antifungal therapy between antifungal therapeutic classes. The
secondary effectiveness endpoints for study aim 1 are comparative effectiveness of the 1)
global response to antifungal therapy after 30 days and 2) all-cause mortality at 30 days.
The secondary aim is to characterize the frequency of pediatric candidiasis by describing the
incidence of pediatric candidiasis relative to all pediatric admissions. For this aim, the
investigators will use descriptive statistics to establish the frequency of hospital
admissions involving an invasive candidiasis per total hospital admissions and total hospital
days during the study period.
comparative effectiveness study.
The primary aim of this study is to compare the effectiveness of echinocandin versus
amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for
invasive candidemia. The primary effectiveness endpoint for study aim 1 is the comparison of
global response at 14 days of antifungal therapy between antifungal therapeutic classes. The
secondary effectiveness endpoints for study aim 1 are comparative effectiveness of the 1)
global response to antifungal therapy after 30 days and 2) all-cause mortality at 30 days.
The secondary aim is to characterize the frequency of pediatric candidiasis by describing the
incidence of pediatric candidiasis relative to all pediatric admissions. For this aim, the
investigators will use descriptive statistics to establish the frequency of hospital
admissions involving an invasive candidiasis per total hospital admissions and total hospital
days during the study period.
Inclusion Criteria:
1. Males or females age > 120 days and <18 years
2. Documented proven or probable case of invasive candidiasis
3. Parental/guardian permission (informed consent, if required) and if appropriate, child
assent (if required).
Exclusion Criteria:
1) Any history of prior Candida infection within the previous 35 days (These patients will
not be eligible for analysis in aim 1 but will be eligible for inclusion of aim 2)
We found this trial at
28
sites
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
Click here to add this to my saved trials
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
Click here to add this to my saved trials
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 267-426-5570
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
Click here to add this to my saved trials
Click here to add this to my saved trials
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Click here to add this to my saved trials
Click here to add this to my saved trials
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
Click here to add this to my saved trials
Click here to add this to my saved trials
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
Click here to add this to my saved trials
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
Click here to add this to my saved trials