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Trial record 33 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01782131
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of posaconazole (POS) versus voriconazole (VOR) in the treatment of adults and adolescents with invasive aspergillosis (IA). The primary hypothesis is that the all-cause mortality through Day 42 in the POS treatment group is non-inferior to that in the VOR treatment group.

Condition or disease Intervention/treatment Phase
Fungal Infections Drug: Posaconazole Drug: Voriconazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents (Phase 3; Protocol No. MK-5592-069)
Actual Study Start Date : September 25, 2013
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : September 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: Posaconazole
Participants will start therapy with a posaconazole loading dose of 300 mg intravenously (IV) twice per day (BID) on Day 1, and then will receive posaconazole IV 300 mg once per day (QD) starting on Day 2 until clinically stable when participants will transition to oral therapy with posaconazole 300 mg tablets QD for up to a total of 12 weeks of treatment. Participants with renal insufficiency or without central venous catheter access may start study treatment with a loading dose of oral posaconazole 300 mg tablets BID on Day 1, and then 300 mg QD for up to a total of 12 weeks of treatment.
Drug: Posaconazole
Other Names:
  • SCH 056592
  • MK-5592
  • Noxafil®

Active Comparator: Voriconazole
Participants will start therapy with a voriconazole loading dose of 6 mg/kg of body weight IV BID on Day 1, and then will receive voriconazole IV 4 mg/kg of body weight IV BID starting on Day 2 until clinically stable when participants will transition to oral therapy with voriconazole 200 mg capsules BID for up to a total of 12 weeks of treatment. Participants with renal insufficiency or without central venous catheter access may start study treatment with a loading dose of oral voriconazole 300 mg capsules BID on Day 1, and then 200 mg BID for up to a total of 12 weeks of treatment.
Drug: Voriconazole
Other Name: VFEND®




Primary Outcome Measures :
  1. Number of Participants Who Died by Day 42 [ Time Frame: Up to Day 42 ]

Secondary Outcome Measures :
  1. Number of Participants Achieving Global Clinical Response at Week 12 [ Time Frame: Week 12 ]
  2. Number of Participants Who Died by Day 84 [ Time Frame: Up to Day 84 ]
  3. Time to Death [ Time Frame: Up to Week 16 ]
  4. Number of Participants Achieving Global Clinical Response at Week 6 [ Time Frame: Week 6 ]
  5. Number of Participants Who Died Due to Invasive Aspergillosis by Day 84 [ Time Frame: Up to Day 84 ]
  6. Number of Participants Who Died Due to Invasive Aspergillosis by Day 42 [ Time Frame: Up to Day 42 ]
  7. Number of participants with an Adverse Event [ Time Frame: Up to approximately week 16 ]
  8. Number of participants who discontinued study treatment due to an Adverse Event [ Time Frame: Up to approximately week 12 ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight >40 kg (88 lb) and ≤150 kg (330 lb); if between 13 and 14 years of age must weigh >= 50 kg (110 lb)
  • Must meet the criteria for proven, probable, or possible IA. If with possible IA at time of randomization must be willing or be in process of an ongoing diagnostic work up which is anticipated to result in a mycological diagnosis of proven or probable IA post-randomization
  • Must have a central line (e.g., central venous catheter, peripherally-inserted central catheter, etc.) in place or planned to be in place prior to beginning IV study therapy. If without central catheter access, must be clinically stable and able to receive oral study therapy
  • Acute IA defined as duration of clinical syndrome of <30 days.
  • Female participants of child-bearing potential must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use for 30 days after stopping study medication
  • Is not taking prohibited antifungal prophylaxis or treatment

Exclusion Criteria:

  • Chronic (>1 month duration) IA, relapsed/recurrent IA, or refractory IA which has not responded to antifungal therapy.
  • Chronic pulmonary aspergillosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis (ABPA).
  • Known mixed invasive mold fungal infection including Zygomycetes, and/or a known invasive Aspergillus fungal infection in which either study drug may not be considered active.
  • Receipt of any systemic (oral, intravenous, or inhaled) antifungal therapy for this infection episode for 4 or more consecutive days (>= 96 hours) immediately before randomization.
  • Developed the current episode of IA infection during receipt of >13 days of antifungal prophylaxis with an agent considered to be a mold-active antifungal agent.
  • Receipt of posaconazole or voriconazole as empirical treatment for this infection for 4 days (96 hours) or more within the 15 days immediately before randomization.
  • Known hypersensitivity or other serious adverse reaction to any azole antifungal therapy or to any other ingredient of the study medication used.
  • Females who are pregnant, intend to become pregnant, or are nursing at the time of randomization.
  • Known history of Torsade de Pointes, unstable cardiac arrhythmia or proarrhythmic conditions, or a history of recent myocardial infarction within 90 days of study entry.
  • Has significant liver dysfunction
  • Hepatic cirrhosis or a Child-Pugh score of C (severe hepatic impairment) at the time of randomization.
  • Severe renal insufficiency (estimated creatinine clearance <20 mL/min) or on

hemodialysis at the time of randomization or likely to require dialysis during the study.

  • Known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Acute symptomatic pancreatitis within 6 months of study entry or a diagnosis of chronic pancreatitis at the time of randomization.
  • Active skin lesion consistent with squamous cell carcinoma at the time of randomization, or a current or prior history of malignant melanoma within 5 years of study entry.
  • On artificial ventilation or receiving acute Continuous Positive Airway Pressure (CPAP)/Bilevel Positive Airway Pressure (BPAP) at the time of randomization.
  • Known or suspected Gilbert's disease at the time of randomization.
  • Requires treatment with other medications that cannot be stopped and for which there is a known contraindication to co-administration of one or more of the study drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782131


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01782131     History of Changes
Other Study ID Numbers: P06200
2011-003938-14 ( EudraCT Number )
5592-069 ( Other Identifier: Merck )
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Aspergillosis
Cytochrome P-450 CYP3A Inhibitors
Mycoses
Voriconazole
Posaconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents