ClinicalTrials.gov record
Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT01307579
Public ClinicalTrials.gov record NCT01307579. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized phase III trial compares the effectiveness of caspofungin to fluconazole in preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for prophylaxis in children is not known. Caspofungin has activity against yeast and some molds while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that agents with activity against yeasts and molds are more effective than those with just activity against yeasts. There are limited data to answer this comparative question in children. This study will establish much needed pediatric data to guide clinical decision making on optimal antifungal prophylaxis.
Study identification
- NCT ID
- NCT01307579
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 517 participants
Conditions and interventions
Conditions
- Acute Myeloid Leukemia
- Adult Acute Monoblastic Leukemia
- Adult Acute Monocytic Leukemia
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With Maturation
- Adult Acute Myeloid Leukemia With Minimal Differentiation
- Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
- Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
- Adult Acute Myeloid Leukemia Without Maturation
- Adult Acute Myelomonocytic Leukemia
- Alkylating Agent-Related Acute Myeloid Leukemia
- Childhood Acute Monoblastic Leukemia
- Childhood Acute Monocytic Leukemia
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Acute Myeloid Leukemia With Maturation
- Childhood Acute Myeloid Leukemia With Minimal Differentiation
- Childhood Acute Myeloid Leukemia Without Maturation
- Childhood Acute Myelomonocytic Leukemia
- Fungal Infection
- Myeloid Neoplasm
- Neutropenia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Untreated Adult Acute Myeloid Leukemia
- Untreated Childhood Myeloid Neoplasm
Interventions
- Caspofungin Acetate Drug
- Fluconazole Drug
- Laboratory Biomarker Analysis Other
Drug · Other
Eligibility (public fields only)
- Age range
- 3 Months to 30 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 4, 2011 (Actual)
- Primary completion
- Jun 30, 2018 (Actual)
- Completion
- Jun 30, 2020 (Actual)
- Last update posted
- Mar 30, 2021
2011 – 2020
United States locations
- U.S. sites
- 166
- U.S. states
- 46
- U.S. cities
- 128
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Lee Memorial Health System | Fort Myers | Florida | 33901 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| Florida Hospital Orlando | Orlando | Florida | 32803 | — |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | — |
| UF Cancer Center at Orlando Health | Orlando | Florida | 32806 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | — |
| Saint Mary's Hospital | West Palm Beach | Florida | 33407 | — |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | 46260 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Ascension Saint John Hospital | Detroit | Michigan | 48236 | — |
| Michigan State University Clinical Center | East Lansing | Michigan | 48824-7016 | — |
| Hurley Medical Center | Flint | Michigan | 48503 | — |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | 49008 | — |
| Beaumont Children's Hospital-Royal Oak | Royal Oak | Michigan | 48073 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Columbia Regional | Columbia | Missouri | 65201 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | — |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | — |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | — |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Overlook Hospital | Summit | New Jersey | 07902 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| NYU Winthrop Hospital | Mineola | New York | 11501 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Columbia University/Herbert Irving Cancer Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Mission Hospital Inc-Memorial Campus | Asheville | North Carolina | 28801 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio | 43606 | — |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | 74136 | — |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Greenville Cancer Treatment Center | Greenville | South Carolina | 29605 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | 79106 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| University of Vermont College of Medicine | Burlington | Vermont | 05405 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | — |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | — |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01307579, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 30, 2021 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01307579 live on ClinicalTrials.gov.