A Phase 2, Open-Label, Non-Comparative Clinical Trial to Study the Safety and Efficacy of Posaconazole (POS, MK-5592) in Pediatric Participants Aged 2 to Less Than 18 Years With Invasive Aspergillosis
Who is this study for? Child patients with Invasive Aspergillosis
What treatments are being studied? Posaconazole
Status: Completed
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to \<18 years of age with invasive aspergillosis (IA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Has a diagnosis of possible, probable, or proven IA per modified 2008/2020 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) disease definitions
• 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.
Locations
United States
California
Children's Hospital of Orange County ( Site 1409)
Orange
Rady Children's Hospital-San Diego ( Site 1401)
San Diego
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1402)
Chicago
Missouri
Washington University ( Site 1403)
St Louis
Other Locations
Belgium
UCL St Luc ( Site 1000)
Brussels
UZ Gent ( Site 1002)
Ghent
UZ Leuven ( Site 1001)
Leuven
Greece
Athens Childrens Hospital Aglaia Kyriakou ( Site 1052)
Athens
General Hospital of Thessaloniki Ippokrateio ( Site 1050)
Thessaloniki
University General Hospital of Thessaloniki AHEPA ( Site 1053)
Thessaloniki
Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 1102)
Budapest
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 1103)
Budapest
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 1101)
Miskolc
Israel
Rambam Medical Center ( Site 1125)
Haifa
Hadassah Ein Karem Hebrew University Medical Center ( Site 1127)
Jerusalem
Chaim Sheba Medical Center ( Site 1126)
Ramat Gan
Sourasky Medical Center ( Site 1128)
Tel Aviv
Italy
Ospedale Regina Margherita ( Site 1150)
Torino
Azienda Ospedaliera Universitaria Integrata ( Site 1151)
Verona
Mexico
Instituto Nacional de Pediatria ( Site 1200)
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Infectologia ( Site 1204)
Monterrey
Peru
Hospital Nacional Edgardo Rebagliati Martins ( Site 1250)
Lima
Instituto Nacional de Enfermedades Neoplásicas ( Site 1251)
Lima
Republic of Korea
Seoul National University Hospital ( Site 1326)
Seoul
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1325)
Seoul
Russian Federation
Dmitry Rogachev National Research Center ( Site 1275)
Moscow
Almazov National Medical Research Centre ( Site 1284)
Saint Petersburg
Institute of Child Hematology and Transpl n.a.R.M.Gorbacheva ( Site 1281)
Saint Petersburg
Institute of Invasive Mycosis ( Site 1282)
Saint Petersburg
Time Frame
Start Date:2020-07-02
Completion Date:2023-12-18
Participants
Target number of participants:31
Treatments
Experimental: 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.