Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
NCT ID: NCT04218851
Last Updated: 2025-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2020-07-02
2023-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Posaconazole
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation.
Posaconazole IV
Posaconazole (POS) 6 mg/kg body weight by IV infusion
Posaconazole PFS
Dosing based on weight-band taken orally
Posaconazole tablet
POS tablet 300 mg taken orally
Interventions
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Posaconazole IV
Posaconazole (POS) 6 mg/kg body weight by IV infusion
Posaconazole PFS
Dosing based on weight-band taken orally
Posaconazole tablet
POS tablet 300 mg taken orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has one or more of pre-defined risks as per modified 2008 EORTC/MSG disease definitions
* Has a central line (e.g., central venous catheter, peripherally-inserted central catheter) in place or planned to be in place prior to beginning IV study treatment.
* Has clinical symptoms consistent with an acute episode of IA, defined as duration of clinical syndrome of \<30 days.
* Participants weigh at least 10 kg, and may be of any race/ethnicity.
* During the intervention period and for at least 30 days after the last dose of study treatment, males agree to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
* Female is not pregnant or breastfeeding, and is not a woman of child bearing potential (WOCBP) or is a WOCBP using a highly effective contraceptive method. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
Exclusion Criteria
* Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
* Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study treatment used.
* Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of time of first dose of study treatment.
* Has known hereditary fructose intolerance.
* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
* Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
* Is on artificial ventilation at the time of first dose of study treatment.
* Has received any treatment prohibited by the protocol.
* Has enrolled previously in the current study and been discontinued.
* Is not expected, in the opinion of the investigator, to survive for at least 1 month after the initiation of study treatment.
2 Years
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Children's Hospital of Orange County ( Site 1409)
Orange, California, United States
Rady Children's Hospital-San Diego ( Site 1401)
San Diego, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1402)
Chicago, Illinois, United States
Washington University ( Site 1403)
St Louis, Missouri, United States
UCL St Luc ( Site 1000)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Gent ( Site 1002)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 1001)
Leuven, Vlaams-Brabant, Belgium
Athens Childrens Hospital Aglaia Kyriakou ( Site 1052)
Athens, Attica, Greece
University General Hospital of Thessaloniki "AHEPA" ( Site 1053)
Thessaloniki, Central Macedonia, Greece
General Hospital of Thessaloniki "Ippokrateio" ( Site 1050)
Thessaloniki, , Greece
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 1101)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 1103)
Budapest, , Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 1102)
Budapest, , Hungary
Rambam Medical Center ( Site 1125)
Haifa, , Israel
Hadassah Ein Karem Hebrew University Medical Center ( Site 1127)
Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 1126)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 1128)
Tel Aviv, , Israel
Ospedale Regina Margherita ( Site 1150)
Torino, , Italy
Azienda Ospedaliera Universitaria Integrata ( Site 1151)
Verona, , Italy
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 1204)
Monterrey, Nuevo León, Mexico
Instituto Nacional de Pediatria ( Site 1200)
Mexico City, , Mexico
Instituto Nacional de Enfermedades Neoplásicas ( Site 1251)
Lima, , Peru
Hospital Nacional Edgardo Rebagliati Martins ( Site 1250)
Lima, , Peru
Almazov National Medical Research Centre ( Site 1284)
Saint Petersburg, Leningradskaya Oblast', Russia
Dmitry Rogachev National Research Center ( Site 1275)
Moscow, Moscow, Russia
Institute of Invasive Mycosis ( Site 1282)
Saint Petersburg, Sankt-Peterburg, Russia
Institute of Child Hematology and Transpl n.a.R.M.Gorbacheva ( Site 1281)
Saint Petersburg, Sankt-Peterburg, Russia
Seoul National University Hospital ( Site 1326)
Seoul, , South Korea
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1325)
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-5592-104
Identifier Type: OTHER
Identifier Source: secondary_id
2019-002267-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
5592-104
Identifier Type: -
Identifier Source: org_study_id
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