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Clinical Trials/EUCTR2019-002267-10-IT
EUCTR2019-002267-10-ITActive, not recruitingPhase 1

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 <18 Years With Invasive Aspergillosis -

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites30 target enrollmentStarted: June 15, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •A participant will be eligible for inclusion in the study if the participant:
  • •1. Has a diagnosis of possible, probable, or proven IA per modified 2008 EuropeanOrganization for Research and Treatment of Cancer/Mycoses Study Group(EORTC/MSG) disease definitions.
  • •2. If enrolled with a possible or probable IA diagnosis, has one or more of the following risks as per modified 2008 EORTC/MSG disease definitions:
  • •- Recent history of neutropenia (<0.5 x 109 neutrophils/L[<500 neutrophils/mm3]) (within 30 days before to screening).
  • •- Receipt of an allogeneic HSCT.
  • •-Treatment with other recognized T-cell immune suppressants, such as cyclosporine, TNF-a blockers, specific monoclonal antibodies (such as alemtuzumab), or nucleoside analogues during the past 90 days.
  • •- Prolonged use corticosteroids for >3 weeks (average minimum dose of 0.3 mg/kg/day of prednisone equivalent).
  • •- Congenital or inherited severe immunodeficiency (including but not limited to chronic granulomatous disease or severe combined immunodeficiency).
  • •3. If enrolled with a possible or probable IA diagnosis, meets mycologic and clinical criteria as per modified 2008 EORTC/MSG disease definitions:
  • •- Possible IA includes participants with clinical criteria, with the anticipation that further diagnostic workup is in progress and is anticipated to result in a diagnosis of probable IA.
  • •- Probable IA includes participants with clinical criteria, along with
  • •mycological criteria including serum or broncho-alveolar lavage (BAL) fluid, Aspergillus galactomannan antigen, or evidence of Aspergillus by histology or microscopy, or positive culture of a specimen taken by nonsterile sampling of an infected site.
  • •4. If enrolled with a proven IA diagnosis, has demonstrated fungal elements (by cytology or microscopy) or positive culture for Aspergillus obtained by sterile sampling of diseased tissue as per modified 2008 EORTC/MSG disease definitions.
  • •5. Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study treatment.
  • •6. Has clinical symptoms consistent with an acute episode of IA, defined as duration of clinical syndrome of <30 days.
  • •7. Is male or female, and >=2 years of age and <18 years of age at the time of first dose of study treatment. Participants may be of any race/ethnicity.
  • •- Contraceptive use by males should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • •8. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days] after the last dose of study treatment:
  • •- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
  • •- Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause as detailed below:
  • •- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a female of childbearing potential who is not currently pregnant.
  • •Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • •For remaining criteria refer to protocol
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number

Exclusion Criteria

  • •The participant must be excluded from the study if the participant:
  • •1. Has chronic (=30 days’ duration) IA, relapsed/recurrent IA, or refractory IA that has not responded to prior antifungal treatment.
  • •2. Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • •3. Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study treatment used.
  • •4. 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.
  • •5. Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • •6. Is on artificial ventilation or receiving acute continuous positive airway pressure (CPAP)/bilevel positive airway pressure (BPAP) at the time of first dose of study treatment.
  • •7. Has known or suspected Gilbert’s disease.
  • •8. Has any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
  • •9. Has received any treatment specifically listed in the Protocol within the specified timeframes before the start of study treatment.
  • •10. Has enrolled previously in the current study and been discontinued.
  • •11. Has QTc prolongation (based on either Fridericia or Bazett’s correction) at screening >500 msec.
  • •12. Has significant liver dysfunction (defined as total bilirubin >1.5 times ULN AND AST or ALT >3 times ULN with normal alkaline phosphatase) at screening.
  • •13. Has calculated creatinine clearance <20 mL/min (Cockroft-Gault formula) or<20 mL/min/1.73m2 (modified Schwartz formula) at screening.
  • •14. Is not expected, in the opinion of the investigator, to survive for at least 1 month after the initiation of study treatment.
  • •15. 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.

Investigators

Sponsor
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

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