A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)

NCT00550732 | Completed Phase 2 Results DMC

• 1 other identifier: P05090
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early treatment of fungal infections in participants who are refractory to, intolerant to, or medically precluded from first-line monotherapy or first-line combination antifungal therapy.

Conditions

Mycoses

Keywords

Triazoles

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment

  Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.

  Up to 6 months

Secondary Outcomes (7)

• Number of Participants With ≥50% Decrease in Lesion Size or Number

  Up to 6 months

• Percentage of Participants With a CR or PR by 12 Weeks

  Up to 12 Weeks

• Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks

  Up to 26 weeks

• Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug

  Up to 6 months

• Overall Survival at 3 Months

  3 months

Study Arms (1)

Posaconazole

EXPERIMENTAL

Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.

Drug: Posaconazole

Interventions

Posaconazole DRUG

Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.

Also known as: SCH056592, Noxafil®

Posaconazole

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven or probable invasive fungal infection (IFI) including breakthrough infection while on antifungal treatment for at least 7 days.
• Refractory or intolerant to prior antifungal therapy, or medically unable to receive standard antifungal therapy.
• Age ≥13 years old.
• Expected to survive \>1 month.
• Negative pregnancy test (serum or urine) at baseline for women of childbearing potential.

You may not qualify if:

• Serum bilirubin \>10 times upper limit of normal (ULN).
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>10 times ULN.
• Documented allergy to azoles.
• Unable to take oral suspension medications or enteral feeding.
• Pregnant or breastfeeding.
• Participants who have received an investigational drug are allowed to be enrolled if the investigational drug was given 30 days prior to study registration, unless approved by the Sponsor.
• Requires surgery.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• JSS Medical Research Inc.: collaborator

MeSH Terms

Conditions

Mycoses

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Globalo 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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: December 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 7, 2017
• Results First Posted: December 27, 2013

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share