NCT00704951

Brief Summary

The purpose of this program is to determine the frequency of the use of Posaconazole in immunocompromised patients refractory to first line therapy receiving therapeutic treatment based on different pathogens in comparison to other antifungal therapy. A further objective is to determine the frequency of the use of Posaconazole in immunocompromised patients receiving prophylactic treatment in comparison to other antifungal prophylaxis.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

June 23, 2008

Last Update Submit

August 24, 2015

Conditions

Mycoses

Outcome Measures

Primary Outcomes (1)

  • Safety: adverse events

    Depending on treatment modality every 2 to 4 weeks

Secondary Outcomes (3)

  • Baseline: Patient demographic data; Disease history; Underlying diseases; Diagnosis; Previous therapies; Environmental risk factors; Host factors Performance status

    Depending on treatment modality every 2 to 4 weeks

  • Treatment and follow up period: Performance status; Medication; Duration of treatment; Frequency of infectious episodes; Management of infections

    Depending on treatment modality every 2 to 4 weeks

  • Adverse events; Survival status

    Depending on treatment modality every 2 to 4 weeks

Study Arms (1)

Patients

Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

Drug: Posaconazole or alternative fungal treatment

Interventions

Posaconazole or alternative fungal treatmentDRUG

Dosage of Posaconazole: Prophylactic dosing: 200mg tid (600mg/day) Treatment dosing: 400mg bid (800mg/day)

Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

You may qualify if:

  • Immunocompromised patients with refractory IFI
  • Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mycoses

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

August 25, 2015

Record last verified: 2015-08