Invasive AspergillosisPhase 2NCT04218851
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
A Phase 2 study testing Posaconazole IV, Posaconazole PFS and Posaconazole tablet in people with Invasive Aspergillosis, run by Merck Sharp & Dohme LLC at 29 sites in 10 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- Posaconazole IV, Posaconazole PFS and Posaconazole tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 29 sitesin 10 countries
- Study dates
- 2 Jul 2020to 18 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
29 sites in 10 countries.
29 sites in 10 countries
United States4 sites
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1402)
Chicago, Illinois, 60611
Children's Hospital of Orange County ( Site 1409)
Orange, California, 92868
Rady Children's Hospital-San Diego ( Site 1401)
San Diego, California, 92123
Washington University ( Site 1403)
St Louis, Missouri, 63110
Israel4 sites
Rambam Medical Center ( Site 1125)
Haifa, 3525408
Hadassah Ein Karem Hebrew University Medical Center ( Site 1127)
Jerusalem, 9112001
Chaim Sheba Medical Center ( Site 1126)
Ramat Gan, 5262100
Sourasky Medical Center ( Site 1128)
Tel Aviv, 6423906
Russia4 sites
Dmitry Rogachev National Research Center ( Site 1275)
Moscow, Moscow, 117198
Almazov National Medical Research Centre ( Site 1284)
Saint Petersburg, Leningradskaya Oblast', 197341
Institute of Invasive Mycosis ( Site 1282)
Saint Petersburg, Sankt-Peterburg, 194291
Institute of Child Hematology and Transpl n.a.R.M.Gorbacheva ( Site 1281)
Saint Petersburg, Sankt-Peterburg, 197022
Belgium3 sites
UCL St Luc ( Site 1000)
Brussels, Bruxelles-Capitale, Region de, 1200
UZ Gent ( Site 1002)
Ghent, Oost-Vlaanderen, 9000
UZ Leuven ( Site 1001)
Leuven, Vlaams-Brabant, 3000
Greece3 sites
Athens Childrens Hospital Aglaia Kyriakou ( Site 1052)
Athens, Attica, 115 27
University General Hospital of Thessaloniki "AHEPA" ( Site 1053)
Thessaloniki, Central Macedonia, 546 36
General Hospital of Thessaloniki "Ippokrateio" ( Site 1050)
Thessaloniki, 546 42
Hungary3 sites
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 1103)
Budapest, 1089
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 1102)
Budapest, 1097
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 1101)
Miskolc, Borsod-Abauj Zemplen county, 3526
Italy2 sites
Ospedale Regina Margherita ( Site 1150)
Torino, 10126
Azienda Ospedaliera Universitaria Integrata ( Site 1151)
Verona, 37126
Mexico2 sites
Instituto Nacional de Pediatria ( Site 1200)
Mexico City, 04530
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 1204)
Monterrey, Nuevo León, 64460
Peru2 sites
Instituto Nacional de Enfermedades Neoplásicas ( Site 1251)
Lima, 15038
Hospital Nacional Edgardo Rebagliati Martins ( Site 1250)
Lima, 15072
South Korea2 sites
Seoul National University Hospital ( Site 1326)
Seoul, 03080
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1325)
Seoul, 06591
About this study
Official title: 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).
- Conditions
- Invasive Aspergillosis
- Being tested
- Posaconazole IV, Posaconazole PFS, Posaconazole tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posaconazole IVDrug
Also called MK-5592, SCH 056592, Noxafil®
Posaconazole (POS) 6 mg/kg body weight by IV infusion
Posaconazole PFSDrug
Also called MK-5592, SCH 056592, Noxafil®
Dosing based on weight-band taken orally
Posaconazole tabletDrug
Also called MK-5592, SCH 056592, Noxafil®
POS tablet 300 mg taken orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Posaconazole IV; Drug: Posaconazole PFS; Drug: Posaconazole tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling.
Measured: Up to week 6
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12
A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling.
Measured: Up to Week 12
Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response
In participants who achieved favorable global clinical response, relapse of IA is defined as the re-emergence of clinical, radiographic, or other relevant abnormalities indicating IA.
Measured: Up to 28 days post-treatment (up to Day 116)
Average Plasma Concentration (Cavg) of POS by Age Cohorts
Steady state Cavg was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cavg parameter values (1 for IV dosing, 1 for oral dosing).
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum Plasma Concentration (Cmin) of POS by Age Cohorts
Steady state Cmin was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmin parameter values (1 for IV dosing, 1 for oral dosing).
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum Plasma Concentration (Cmax) of POS by Age Cohorts
Steady state Cmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmax parameter values (1 for IV dosing, 1 for oral dosing).
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts
Steady state AUCtau was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 AUCtau parameter values (1 for IV dosing, 1 for oral dosing).
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to Reach Cmax (Tmax) of POS by Age Cohorts
Steady state Tmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Tmax parameter values (1 for IV dosing, 1 for oral dosing).
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Average Plasma Concentration (Cavg) of POS by Formulation
Steady-state Cavg was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2.
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum Plasma Concentration (Cmin) of POS by Formulation
Steady-state Cmin was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2.
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum Plasma Concentration (Cmax) of POS by Formulation
Steady-state Cmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2.
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation
Steady-state AUCtau was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2.
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to Reach Cmax (Tmax) of POS by Formulation
Steady-state Tmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2.
Measured: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation
Palatability was categorized on the first day (Day 8) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group. Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad.
Measured: First day of PFS treatment (Day 8)
Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation
Palatability was categorized on the last day (Day 85) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad.
Measured: Last day of PFS treatment (Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start2 Jul 2020
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218851
- Sponsor's protocol ID
- 5592-104
- Other IDs
- MK-5592-104, 2019-002267-10, 2019
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2020
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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 Mar 4;70(3):e0130525. doi: 10.1128/aac.01305-25. Epub 2026 Jan 27.
PubMed 41589852
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04218851
- Acronym / sponsor ID
- 5592-104
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posaconazole | Experimental | Drug: Posaconazole IV, Drug: Posaconazole PFS, Drug: Posaconazole tabletOn 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posaconazole IVAlso: MK-5592, SCH 056592, Noxafil®Posaconazole (POS) 6 mg/kg body weight by IV infusion | Drug | Posaconazole |
| Posaconazole PFSAlso: MK-5592, SCH 056592, Noxafil®Dosing based on weight-band taken orally | Drug | Posaconazole |
| Posaconazole tabletAlso: MK-5592, SCH 056592, Noxafil®POS tablet 300 mg taken orally | Drug | Posaconazole |
Primary outcome
Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs)
Time frame: Up to 14 days after treatment (up to Day 102)
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.
15 secondary outcomes
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6
Time frame: Up to week 6
Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12
Time frame: Up to Week 12
Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response
Time frame: Up to 28 days post-treatment (up to Day 116)
Average Plasma Concentration (Cavg) of POS by Age Cohorts
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum Plasma Concentration (Cmin) of POS by Age Cohorts
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum Plasma Concentration (Cmax) of POS by Age Cohorts
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to Reach Cmax (Tmax) of POS by Age Cohorts
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Average Plasma Concentration (Cavg) of POS by Formulation
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Minimum Plasma Concentration (Cmin) of POS by Formulation
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Maximum Plasma Concentration (Cmax) of POS by Formulation
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Time to Reach Cmax (Tmax) of POS by Formulation
Time frame: Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12
Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation
Time frame: First day of PFS treatment (Day 8)
Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation
Time frame: Last day of PFS treatment (Day 85)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41589852Kang 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 Mar 4;70(3):e0130525. doi: 10.1128/aac.01305-25. Epub 2026 Jan 27.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
29 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posaconazole IV, Posaconazole PFS and Posaconazole tablet in people with Invasive Aspergillosis, run by Merck Sharp & Dohme LLC at 29 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Israel, Russia, Belgium, Greece and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) (time frame: Up to 14 days after treatment (up to Day 102)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.