A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069/P06200)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01782131
First received: January 30, 2013
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of posaconazole versus voriconazole in the treatment of adults with invasive aspergillosis (IA).


Condition Intervention Phase
Fungal Infections
Drug: Posaconazole
Drug: Voriconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 (Phase 3; Protocol No. MK-5592-069)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Achieving Global Clinical Response at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Achieving Global Clinical Response at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Who Died by Week 6 [ Time Frame: Up to Week 6 ] [ Designated as safety issue: No ]
  • Number of Participants Who Died by Week 12 [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • Time to Clinical Global Response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Time to Death [ Time Frame: Up to Week 26 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight >40 kg (88 lb) and ≤150 kg (330 lb)
  • Acute IA defined as duration of clinical syndrome of <30 days.
  • Female subjects 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.

Exclusion Criteria:

  • Chronic (>1 month duration) IA, relapsed/recurrent IA, or refractory IA

which has not responded to antifungal therapy.

  • 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 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782131

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 28 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01782131     History of Changes
Other Study ID Numbers: P06200, 2011-003938-14, 5592-069
Study First Received: January 30, 2013
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Skin Diseases
Voriconazole
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 26, 2014