PEACE: Pediatric Antifungal Comparative Effectiveness (PEACE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01869829 |
|
Recruitment Status :
Completed
First Posted : June 5, 2013
Last Update Posted : January 28, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Pediatric Invasive Candidiasis | Drug: Observational antifungal therapy |
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.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 750 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 7 Weeks |
| Official Title: | International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | April 2018 |
| Actual Study Completion Date : | April 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Pediatric Invasive Candidiasis
Pediatric patients (age > 120 days and < 18 years) with documented proven or probable invasive candidiasis
|
Drug: Observational antifungal therapy
Observational study of primary antifungal therapy utilized and outcomes, including: fluconazole, voriconazole, amphotericin B, caspofungin, and micafungin All agents are given as standard of care. |
- Global response to antifungal therapy [ Time Frame: 14 days ]
- Global response of antifungal therapy [ Time Frame: 30 days ]
- All-cause mortality [ Time Frame: 30 days ]
- Incidence of pediatric invasive fungal infections [ Time Frame: 4 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 120 Days to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Males or females age > 120 days and <18 years
- Documented proven or probable case of invasive candidiasis
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869829
Show 35 study locations
| Principal Investigator: | William J Steinbach, MD | Duke University | |
| Principal Investigator: | Theoklis E Zaoutis, MD MSCE | Children's Hospital of Philadelphia |
Publications of Results:
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01869829 |
| Other Study ID Numbers: |
Pro00045657 1R01AI103315-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 5, 2013 Key Record Dates |
| Last Update Posted: | January 28, 2022 |
| Last Verified: | January 2022 |
|
Candida Pediatric Antifungal |
|
Candidiasis Candidiasis, Invasive Mycoses Bacterial Infections and Mycoses Infections Invasive Fungal Infections Antifungal Agents Clotrimazole Miconazole Anti-Infective Agents Anti-Infective Agents, Local |
14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP3A Inhibitors |