ClinicalTrials.gg
Sign In
WithdrawnNCT00704951Updated Aug 25, 2015

Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

An observational study in Mycoses, sponsored by Merck Sharp & Dohme LLC. Withdrawn. Per ClinicalTrials.gov, last updated 2015-08-25.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study 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.

02

Conditions studied

  • Mycoses

Browse trials for

03

In context

Mycoses

546 studies on the registry are indexed under Mycoses; 56 are open to participants now.

Browse Mycoses studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,163 studies on the registry; 134 are open to participants now.

Of its 498 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • Patients

    Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

    Drug: Posaconazole or alternative fungal treatment

Interventions

  • DrugPosaconazole or alternative fungal treatment

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

06

What researchers measure

Primary outcomes

  1. Safety: adverse events

    Time frame: Depending on treatment modality every 2 to 4 weeks

Secondary outcomes

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

    Time frame: Depending on treatment modality every 2 to 4 weeks

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

    Time frame: Depending on treatment modality every 2 to 4 weeks

  3. Adverse events; Survival status

    Time frame: Depending on treatment modality every 2 to 4 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of May 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2008
First posted
Jun 25, 2008
Start
Jul 2008
Primary completionEst.
May 2011
CompletionEst.
Jun 2011
Last update
Aug 25, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00704951
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 25, 2008
Start date
Jul 2008
Primary completion
May 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
Aug 25, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Mycoses →

Other studies from this sponsor

Merck Sharp & Dohme LLC →

Start the discussion