Phase 2
Completed N=40
A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
Mycoses
Source: ClinicalTrials.gov NCT00550732 ↗
Enrolled (actual)
40
Serious AEs
40.0%
Results posted
Dec 2013
Primary outcomePrimary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment — 26; 46 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment |
26; 46 | — |
| SECONDARY Number of Participants With ≥50% Decrease in Lesion Size or Number |
— | — |
| SECONDARY Percentage of Participants With a CR or PR by 12 Weeks |
75 | — |
| SECONDARY Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks |
6; 26; 28; 48 | — |
| SECONDARY Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug |
56 | — |
| SECONDARY Overall Survival at 3 Months |
85 | — |
| SECONDARY Number of Participants With Response to Posaconazole in Combination Therapy |
— | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) |
39 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00550732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.