Pediatric Invasive Candidiasis Clinical Trial
— PEACEOfficial title:
International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis
| Verified date | January 2022 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 120 Days to 18 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | |
| Colombia | Centro de Estudios en Infectologia Pediatricia | Cali | |
| Colombia | Centro Medico Imbanaco | Cali | |
| Greece | 3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital | Thessaloniki | |
| India | Postgraduate Institute of Medical Education and Research | Chandigarh | |
| Italy | Instuto Giannina Gaslini | Genoa | |
| Saudi Arabia | King Faisal Specialist Hospital & Research Center | Riyadh | |
| Spain | Hospital d'Universitari Vall d'Hebron | Barcelona | |
| United States | Mott Children's Hospital | Ann Arbor | Michigan |
| United States | Children's Hospital Colorado | Aurora | Colorado |
| United States | Dell Children's Medical Center | Austin | Texas |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Ann and Robert Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Cincinnati Children's Medical Center | Cincinnati | Ohio |
| United States | Cleveland Clinic Children's | Cleveland | Ohio |
| United States | Duke University | Durham | North Carolina |
| United States | Texas Children's Hospital | Houston | Texas |
| United States | Children's Mercy | Kansas City | Missouri |
| United States | Arkansas Children's Hospital | Little Rock | Arkansas |
| United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Children's Hospital and Clinics of Minnesota | Minneapolis | Minnesota |
| United States | Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee |
| United States | Cohen Children's Medical Center of New York | New Hyde Park | New York |
| United States | New York Presbyterian Phyllis and David Komansky Center for Children's Health | New York | New York |
| United States | Children's Hospital of Orange County | Orange | California |
| United States | Lucile Packard Children's Hospital at Stanford | Palo Alto | California |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | OHSU Doernbecher Children's Hospital | Portland | Oregon |
| United States | All Children's Hospital | Saint Petersburg | Florida |
| United States | Rady Children's Hospital | San Diego | California |
| United States | UCSF Benioff Children's Hospital | San Francisco | California |
| United States | Seattle Children's | Seattle | Washington |
| United States | Children's National Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID) |
United States, Canada, Colombia, Greece, India, Italy, Saudi Arabia, Spain,
Fisher BT, Zaoutis TE, Xiao R, Wattier RL, Castagnola E, Pana ZD, Fullenkamp A, Boge CLK, Ross RK, Yildirim I, Palazzi DL, Danziger-Isakov L, Vora SB, Arrieta A, Yin DE, Avilés-Robles M, Sharma T, Tribble AC, Maron G, Berman D, Green M, Sung L, Romero J, — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Incidence of pediatric invasive fungal infections | 4 years | ||
| Primary | Global response to antifungal therapy | 14 days | ||
| Secondary | Global response of antifungal therapy | 30 days | ||
| Secondary | All-cause mortality | 30 days |