A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069 AM1)
This study is not yet open for participant recruitment.
Verified May 2013 by Merck
Information provided by (Responsible Party):
First received: January 30, 2013
Last updated: May 8, 2013
Last verified: May 2013
The purpose of this study is to evaluate the safety and efficacy of posaconazole versus voriconazole in the treatment of adults and adolescents with invasive aspergillosis (IA).
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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)
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
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.
Some participants 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.
- SCH 056592
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.
Some participants 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.
Other Name: VFEND®
|Ages Eligible for Study:
||13 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Weight >40 kg (88 lb) and ≤150 kg (330 lb) for participants ≥13 years of age and ≥50 kg (110 lb) for participants between 13 and 14 years of age.
- 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.
- 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.
- Taking mold-active antifungal prophylaxis and the infection is considered to be a breakthrough (i.e., IA infection that develops after the initiation of 13 days or more of preventative mold-active systemic antifungal therapy).
- 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.
- 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 or melanoma at the time of randomization or history of malignant melanoma within 5 years of study entry.
- On artificial ventilation 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.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
||P06200, 2011-003938-14, 5592-069
|Study First Received:
||January 30, 2013
||May 8, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
14-alpha Demethylase Inhibitors
Molecular Mechanisms of Pharmacological Action