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Completed

NCT Number: NCT00550732

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

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.

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Key information

Conditions

Mycoses Bacterial Infections and Mycoses Infections

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

In the past two decades, invasive fungal infections (IFI) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with IFI. Over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. This has demonstrated the need for the development of a new generation of azoles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SCH056592, Noxafil®

Primary outcomes

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

    Time frame: Up to 6 months

    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.

Secondary outcomes

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

    Time frame: Up to 6 months

    Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease.

  2. Percentage of Participants With a CR or PR by 12 Weeks

    Time frame: Up to 12 Weeks

    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.

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

    Time frame: Up to 26 weeks

    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.

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

    Time frame: Up to 6 months

    Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection.

  5. Overall Survival at 3 Months

    Time frame: 3 months

    Total number of participant survivors was assessed at 3 months.

  6. Number of Participants With Response to Posaconazole in Combination Therapy

    Time frame: Up to 6 months

    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.

  7. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to 12 months

    An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • JSS Medical Research Inc.

Registry information

Official study title

A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study.

Acronym: TIP

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 30, 2007
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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