Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
Completed · Phase 2
Conditions studied: Invasive Aspergillosis
In brief
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).
Key facts
- Study ID
- NCT04218851
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 31
- Starts
- 2020-07-02
- Expected to finish
- 2023-12-18
- Last updated by the study team
- 2025-01-14
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Has chronic (≥30 days' duration) IA, relapsed/recurrent IA, or refractory IA that has not responded to prior antifungal treatment.
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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