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

NCT04218851 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 5592-104MK-5592-1042019-002267-10
• Study Type: interventional
• Target: 31
• Locations: 10 countries
• Sites: 29

Brief 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).

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson.

  Up to 14 days after treatment (up to Day 102)

Secondary Outcomes (15)

• Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6

  Up to week 6

• Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12

  Up to Week 12

• 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 116)

• Average Plasma Concentration (Cavg) of POS by Age Cohorts

  Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12

• Minimum Plasma Concentration (Cmin) of POS by Age Cohorts

  Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12

Study Arms (1)

Posaconazole

EXPERIMENTAL

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.

Drug: Posaconazole IV; Drug: Posaconazole PFS; Drug: Posaconazole tablet

Interventions

Posaconazole IV DRUG

Posaconazole (POS) 6 mg/kg body weight by IV infusion

Also known as: MK-5592, SCH 056592, Noxafil®

Posaconazole

Posaconazole PFS DRUG

Dosing based on weight-band taken orally

Also known as: MK-5592, SCH 056592, Noxafil®

Posaconazole

Posaconazole tablet DRUG

POS tablet 300 mg taken orally

Also known as: MK-5592, SCH 056592, Noxafil®

Posaconazole

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (29)

Children's Hospital of Orange County ( Site 1409)

Orange, California, 92868, United States

Location

Rady Children's Hospital-San Diego ( Site 1401)

San Diego, California, 92123, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1402)

Chicago, Illinois, 60611, United States

Location

Washington University ( Site 1403)

St Louis, Missouri, 63110, United States

Location

UCL St Luc ( Site 1000)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

UZ Gent ( Site 1002)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven ( Site 1001)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Athens Childrens Hospital Aglaia Kyriakou ( Site 1052)

Athens, Attica, 115 27, Greece

Location

University General Hospital of Thessaloniki "AHEPA" ( Site 1053)

Thessaloniki, Central Macedonia, 546 36, Greece

Location

General Hospital of Thessaloniki "Ippokrateio" ( Site 1050)

Thessaloniki, 546 42, Greece

Location

BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 1101)

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 1103)

Budapest, 1089, Hungary

Location

Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 1102)

Budapest, 1097, Hungary

Location

Rambam Medical Center ( Site 1125)

Haifa, 3525408, Israel

Location

Hadassah Ein Karem Hebrew University Medical Center ( Site 1127)

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center ( Site 1126)

Ramat Gan, 5262100, Israel

Location

Sourasky Medical Center ( Site 1128)

Tel Aviv, 6423906, Israel

Location

Ospedale Regina Margherita ( Site 1150)

Torino, 10126, Italy

Location

Azienda Ospedaliera Universitaria Integrata ( Site 1151)

Verona, 37126, Italy

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 1204)

Monterrey, Nuevo León, 64460, Mexico

Location

Instituto Nacional de Pediatria ( Site 1200)

Mexico City, 04530, Mexico

Location

Instituto Nacional de Enfermedades Neoplásicas ( Site 1251)

Lima, 15038, Peru

Location

Hospital Nacional Edgardo Rebagliati Martins ( Site 1250)

Lima, 15072, Peru

Location

Almazov National Medical Research Centre ( Site 1284)

Saint Petersburg, Leningradskaya Oblast', 197341, Russia

Location

Dmitry Rogachev National Research Center ( Site 1275)

Moscow, Moscow, 117198, Russia

Location

Institute of Invasive Mycosis ( Site 1282)

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

Institute of Child Hematology and Transpl n.a.R.M.Gorbacheva ( Site 1281)

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

Seoul National University Hospital ( Site 1326)

Seoul, 03080, South Korea

Location

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1325)

Seoul, 06591, South Korea

Location

Related Publications (1)

• Kang HJ, Arrieta AC, Dhooge C, Kelemen A, Macias-Parra M, Aranda L, Dinikina YV, Kassis I, Cesaro S, Shepherd A, Shah AK, Mackey T, Waskin H, Johnson MG. Phase 2, open-label, noncomparative clinical trial evaluating safety and efficacy of posaconazole in pediatric patients with proven/probable invasive aspergillosis or possible invasive fungal disease. Antimicrob Agents Chemother. 2026 Jan 27:e0130525. doi: 10.1128/aac.01305-25. Online ahead of print.

  PMID: 41589852 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

posaconazole

Results Point of Contact

• Title: Clinical Trials Disclosure
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 6, 2020
• Study Start: July 2, 2020
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (2); HU (3); RU (4); KR (2); BE (3); IL (4); US (4); ME (2); GR (3); PE (2)