Pediatric Invasive CandidiasisPEACENCT01869829
PEACE: Pediatric Antifungal Comparative Effectiveness
An observational study of Pediatric Invasive Candidiasis, run by Duke University at 35 sites in 8 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 120 days to 18 years
- Conditions the study is for
- Pediatric Invasive Candidiasis
- What is being tested?
- Observational antifungal therapy
- How many people
- 750 participants
- Where
- 35 sitesin 8 countries
- Study dates
- Jan 2015to Apr 2018
- How long will I take part?
- 7 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 120 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with invasive candidiasis
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
35 sites in 8 countries.
35 sites in 8 countries
United States27 sites
Mott Children's Hospital
Ann Arbor, Michigan
Children's Hospital Colorado
Aurora, Colorado
Dell Children's Medical Center
Austin, Texas
Boston Children's Hospital
Boston, Massachusetts
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois
Cincinnati Children's Medical Center
Cincinnati, Ohio
Cleveland Clinic Children's
Cleveland, Ohio
Duke University
Durham, North Carolina, 27710
Texas Children's Hospital
Houston, Texas
Children's Mercy
Kansas City, Missouri
Arkansas Children's Hospital
Little Rock, Arkansas
St. Jude Children's Research Hospital
Memphis, Tennessee
Medical College of Wisconsin
Milwaukee, Wisconsin
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee
Cohen Children's Medical Center of New York
New Hyde Park, New York
New York Presbyterian Phyllis and David Komansky Center for Children's Health
New York, New York
Children's Hospital of Orange County
Orange, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania
OHSU Doernbecher Children's Hospital
Portland, Oregon
Rady Children's Hospital
San Diego, California
UCSF Benioff Children's Hospital
San Francisco, California
Seattle Children's
Seattle, Washington
All Children's Hospital
St. Petersburg, Florida
Children's National Medical Center
Washington D.C., District of Columbia
Colombia2 sites
Centro de Estudios en Infectologia Pediatricia
Cali
Centro Medico Imbanaco
Cali
Greece1 site
3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital
Thessaloniki
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Riyadh
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Pediatric Invasive Candidiasis
- Being tested
- Observational antifungal therapy
- Keywords
- Candida, Pediatric, Antifungal
- Medical subject headings
- Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational antifungal therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Invasive Candidiasis | Pediatric patients (age > 120 days and < 18 years) with documented proven or probable invasive candidiasis Receives: Drug: Observational antifungal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global response to antifungal therapy
Measured: 14 days
Secondary outcomes (2)
Global response of antifungal therapy
Measured: 30 days
All-cause mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJan 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Invasive CandidiasisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
- Target duration
- 7 Weeks
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- William J Steinbach, MD, Principal investigator, Duke UniversityTheoklis E Zaoutis, MD MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869829
- Sponsor's protocol ID
- Pro00045657
- Other IDs
- 1R01AI103315-01A1
- Acronym
- PEACE
- Status last verified
- Jan 2022
- First submitted
- 31 May 2013
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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, Aviles-Robles M, Sharma T, Tribble AC, Maron G, Berman D, Green M, Sung L, Romero J, Hauger SB, Roilides E, Belani K, Nolt D, Soler-Palacin P, Lopez-Medina E, Muller WJ, Halasa N, Dulek D, Hussain IZB, Pong A, Hoffman J, Rajan S, Gonzalez BE, Hanisch B, Aftandilian C, Carlesse F, Abzug MJ, Huppler AR, Salvatore CM, Ardura MI, Chakrabarti A, Santolaya ME, Localio AR, Steinbach WJ. Comparative Effectiveness of Echinocandins vs Triazoles or Amphotericin B Formulations as Initial Directed Therapy for Invasive Candidiasis in Children and Adolescents. J Pediatric Infect Dis Soc. 2021 Aug 10:piab024. doi: 10.1093/jpids/piab024. Online ahead of print.
PubMed 34374424
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Pediatric Fungal Network: Multi-Center Studies to Improve Diagnosis and Treatment of Pediatric Candidiasis
- ClinicalTrials.gov ID
- NCT01869829
- Acronym / sponsor ID
- PEACE / Pro00045657
- Conditions
- Pediatric Invasive Candidiasis
- Keywords
- Candida, Pediatric, Antifungal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Invasive Candidiasis | – | Drug: Observational antifungal therapyPediatric patients (age > 120 days and < 18 years) with documented proven or probable invasive candidiasis |
Who may qualify
- Ages
- 120 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with invasive candidiasis
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational antifungal therapyObservational study of primary antifungal therapy utilized and outcomes, including: fluconazole, voriconazole, amphotericin B, caspofungin, and micafungin All agents are given as standard of care. | Drug | Pediatric Invasive Candidiasis |
Primary outcome
Global response to antifungal therapy
Time frame: 14 days
2 secondary outcomes
Global response of antifungal therapy
Time frame: 30 days
All-cause mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Results publication: PubMed 34374424Fisher 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, Aviles-Robles M, Sharma T, Tribble AC, Maron G, Berman D, Green M, Sung L, Romero J, Hauger SB, Roilides E, Belani K, Nolt D, Soler-Palacin P, Lopez-Medina E, Muller WJ, Halasa N, Dulek D, Hussain IZB, Pong A, Hoffman J, Rajan S, Gonzalez BE, Hanisch B, Aftandilian C, Carlesse F, Abzug MJ, Huppler AR, Salvatore CM, Ardura MI, Chakrabarti A, Santolaya ME, Localio AR, Steinbach WJ. Comparative Effectiveness of Echinocandins vs Triazoles or Amphotericin B Formulations as Initial Directed Therapy for Invasive Candidiasis in Children and Adolescents. J Pediatric Infect Dis Soc. 2021 Aug 10:piab024. doi: 10.1093/jpids/piab024. Online ahead of print.
- International Pediatric Fungal NetworkLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Steinbach, MD principal investigator
Duke University
Theoklis E Zaoutis, MD MSCE principal investigator
Children's Hospital of Philadelphia
35 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Invasive Candidiasis, run by Duke University at 35 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Colombia, Canada, Greece, India and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global response to antifungal therapy (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.