Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)

NCT00811642 | Completed Phase 3 Results

• 1 other identifier: P05551
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI

Conditions

Fungal Infection

Keywords

refractory or first line medication intolerable invasive fungal infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment

  EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.

  Treatment week 12

Secondary Outcomes (6)

• Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment

  Treatment week 4

• Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment

  Treatment week 8

• Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment

  Treatment week 4

• Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment

  Treatment week 8

• Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment

  Treatment week 12

Study Arms (1)

Posaconazole

EXPERIMENTAL

Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks

Drug: Posaconazole

Interventions

Posaconazole DRUG

400mg BID oral suspension for 12 weeks

Also known as: Noxafil

Posaconazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18-70 years male or female
• Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment.
• Sign informed consent form

You may not qualify if:

• Female participants who are pregnant or are nursing.
• Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B
• Participants with progressive nervous system diseases( excluding those IFI caused)
• Participants who take the following drugs known with interference with azole antifungal preparations
• terfenadine, cisapride, and ebastine within 24 hours before entry
• astemizole at entry or within 10 days before entry
• cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
• The drugs listed above are prohibited during the investigation
• Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate \<60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
• Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
• Expected to take during investigation or is taking systemic antifungal treatment
• Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are \>2×ULN.
• Participants expected to survive no more than 72hrs
• Participants receiving artificial aeration and will not withdraw within 24hrs
• Participants who have used any investigational drugs or biologic agents or anticipated other clinical trials within 30 days of study entry.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Huang X, Wang F, Chen Y, Liu T, Wang J, Hu J, Jie J, Chen F, Wang S, Shen Z, Yu L, Yu K, Liang Y. A multicenter, open-label study of posaconazole oral suspension in the treatment of invasive fungal infections in patients refractory to or intolerant of first-line therapy. Future Microbiol. 2012 Feb;7(2):201-9. doi: 10.2217/fmb.11.158.

  PMID: 22324990 RESULT

MeSH Terms

Conditions

Mycoses

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 7, 2017
• Results First Posted: April 29, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share