Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)

January 8, 2024 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Bruxelles-Capitale, Region De
      • Brussels, Bruxelles-Capitale, Region De, Belgium, 1200
        • UCL St Luc ( Site 1000)
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 1002)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven ( Site 1001)
      • Thessaloniki, Greece, 546 42
        • General Hospital of Thessaloniki "Ippokrateio" ( Site 1050)
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Athens Childrens Hospital Aglaia Kyriakou ( Site 1052)
    • Kentriki Makedonia
      • Thessaloniki, Kentriki Makedonia, Greece, 546 36
        • University General Hospital of Thessaloniki "AHEPA" ( Site 1053)
      • Budapest, Hungary, 1089
        • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 1103)
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 1102)
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3526
        • BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 1101)
      • Haifa, Israel, 3525408
        • Rambam Medical Center ( Site 1125)
      • Jerusalem, Israel, 9112001
        • Hadassah Ein Karem Hebrew University Medical Center ( Site 1127)
      • Ramat Gan, Israel, 5262100
        • Chaim Sheba Medical Center ( Site 1126)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 1128)
      • Torino, Italy, 10126
        • Ospedale Regina Margherita ( Site 1150)
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata ( Site 1151)
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital ( Site 1326)
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1325)
      • Mexico City, Mexico, 04530
        • Instituto Nacional de Pediatria ( Site 1200)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 1204)
      • Lima, Peru, 15038
        • Instituto Nacional de Enfermedades Neoplásicas ( Site 1251)
      • Lima, Peru, 15072
        • Hospital Nacional Edgardo Rebagliati Martins ( Site 1250)
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 197341
        • Almazov National Medical Research Centre ( Site 1284)
    • Moskva
      • Moscow, Moskva, Russian Federation, 117198
        • Dmitry Rogachev National Research Center ( Site 1275)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194291
        • Institute of Invasive Mycosis ( Site 1282)
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • Institute of Child Hematology and Transpl n.a.R.M.Gorbacheva ( Site 1281)
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County ( Site 1409)
      • San Diego, California, United States, 92123
        • Rady Children's Hospital-San Diego ( Site 1401)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1402)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University ( Site 1403)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a diagnosis of possible, probable, or proven IA per modified 2008 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
  • Meets pre-defined mycologic and clinical criteria as per modified 2008 EORTC/MSG disease definitions
  • Has demonstrated fungal elements (by cytology or microscopy) or positive culture for Aspergillus obtained by sterile sampling of disease tissue as per modified 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 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 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Posaconazole (POS) 6 mg/kg body weight by IV infusion
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
POS PFS 6 mg/kg body weight taken orally
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®
POS tablet 300 mg taken orally
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with Treatment Related Adverse Events (AEs)
Time Frame: Up to 14 days after treatment (up to Day 100)
Percentage of participants who experience one or more treatment-related adverse events (AEs)
Up to 14 days after treatment (up to Day 100)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with a favorable global clinical response
Time Frame: Up to End of Trial (EOT) visit (up to Day 87)
Percentage of participants who have a favorable global clinical response
Up to End of Trial (EOT) visit (up to Day 87)
Participants who have a relapse of invasive aspergillosis (IA)
Time Frame: Up to 28 days post-treatment (up to Day 114)
Percentage of participants who have a relapse of invasive aspergillosis (IA) at any point after achieving favorable global clinical response
Up to 28 days post-treatment (up to Day 114)
Average plasma concentration (Cavg) of Posaconazole (POS)
Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Average plasma concentration (Cavg) of Posaconazole (POS)
Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum plasma concentration (Cmin) of POS
Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum plasma concentration (Cmin) of POS
Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum plasma concentration (Cmax) of POS
Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum plasma concentration (Cmax) of POS
Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area under the concentration-time curve (AUC) of POS
Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area under the concentration-time curve (AUC) of POS
Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to reach Cmax (Tmax) of POS
Time Frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to reach Cmax (Tmax) of POS
Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Participants with different categories of palatability
Time Frame: Day 8 and Day 84
Percentage of participants with different categories of palatability after treatment with the POS PFS formulation
Day 8 and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2020

Primary Completion (Actual)

December 18, 2023

Study Completion (Actual)

December 18, 2023

Study Registration Dates

First Submitted

January 3, 2020

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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