Fungal InfectionPhase 3NCT00811642

Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)

A Phase 3 study testing Posaconazole in people with Fungal Infection, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Fungal Infection
What is being tested?: Posaconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: No sites listed yet
Study dates: Nov 2008to Mar 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must be 18-70 years male or female
Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment.
Sign informed consent form

Who cannot join

Female participants who are pregnant or are nursing.
Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B
Participants with progressive nervous system diseases( excluding those IFI caused)
Participants who take the following drugs known with interference with azole antifungal preparations
terfenadine, cisapride, and ebastine within 24 hours before entry
astemizole at entry or within 10 days before entry

Show all 18Show fewer

cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
The drugs listed above are prohibited during the investigation
Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
Expected to take during investigation or is taking systemic antifungal treatment
Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are >2×ULN.
Participants expected to survive no more than 72hrs
Participants receiving artificial aeration and will not withdraw within 24hrs
Participants who have used any investigational drugs or biologic agents or anticipated other clinical trials within 30 days of study entry.
Prior enrollment in this study.
History of alcohol and/or drug abuse.
Participants cannot be compliant in investigator's opinion.

About this study

Official title: A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection

The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI

Conditions: Fungal Infection
Being tested: Posaconazole
Keywords: refractory or first line medication intolerable invasive fungal infection
Medical subject headings: Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PosaconazoleDrug
Also called Noxafil
400mg BID oral suspension for 12 weeks

Study groups in NCT00811642
Study group	Role	What they receive
Posaconazole	Experimental	Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks Receives: Drug: Posaconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:
Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.
Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.
Stable disease: no progress in IFI attributable symptoms, if present at enrollment.
Failure: deterioration in IFI attributable clinical symptoms.
Measured: Treatment week 12

Secondary outcomes (6)

Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment
EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:
Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.
Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.
Stable disease: no progress in IFI attributable symptoms, if present at enrollment.
Failure: deterioration in IFI attributable clinical symptoms.
Measured: Treatment week 4
Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment
EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:
Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.
Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.
Stable disease: no progress in IFI attributable symptoms, if present at enrollment.
Failure: deterioration in IFI attributable clinical symptoms.
Measured: Treatment week 8
Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment
EVALUATION OF FUNGAL ERADICATION:
Participants' mycological response to therapy was assessed by the following:
Eradication: Negative culture or histologically documented absence of infecting
fungal pathogen from a primary site previously positive.
Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.
Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
Measured: Treatment week 4
Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment
EVALUATION OF FUNGAL ERADICATION:
Participants' mycological response to therapy was assessed by the following:
Eradication: Negative culture or histologically documented absence of infecting
fungal pathogen from a primary site previously positive.
Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.
Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
Measured: Treatment week 8
Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment
EVALUATION OF FUNGAL ERADICATION:
Participants' mycological response to therapy was assessed by the following:
Eradication: Negative culture or histologically documented absence of infecting
fungal pathogen from a primary site previously positive.
Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.
Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen.
Measured: Treatment week 12
Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up
Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.
Measured: Follow-up week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Mar 2010

First posted19 Dec 2008 (estimated)
Study startNov 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fungal InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00811642
Sponsor's protocol ID: P05551
Status last verified: Mar 2017
First submitted: 18 Dec 2008
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Huang X, Wang F, Chen Y, Liu T, Wang J, Hu J, Jie J, Chen F, Wang S, Shen Z, Yu L, Yu K, Liang Y. A multicenter, open-label study of posaconazole oral suspension in the treatment of invasive fungal infections in patients refractory to or intolerant of first-line therapy. Future Microbiol. 2012 Feb;7(2):201-9. doi: 10.2217/fmb.11.158.
PubMed 22324990

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection
ClinicalTrials.gov ID: NCT00811642
Acronym / sponsor ID: P05551
Conditions: Fungal Infection
Keywords: refractory or first line medication intolerable invasive fungal infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 19 Dec 2008 (estimated)
Results: Posted 29 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Posaconazole	Experimental	Drug: PosaconazolePosaconazole 400 mg twice a day (BID) oral suspension for 12 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participants must be 18-70 years male or female
Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment.
Sign informed consent form

Key exclusion criteria (18 listed)

Female participants who are pregnant or are nursing.
Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B
Participants with progressive nervous system diseases( excluding those IFI caused)
Participants who take the following drugs known with interference with azole antifungal preparations
The drugs listed above are prohibited during the investigation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PosaconazoleAlso: Noxafil400mg BID oral suspension for 12 weeks	Drug	Posaconazole

Primary outcome

Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
Time frame: Treatment week 12
EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.

6 secondary outcomes

Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment
Time frame: Treatment week 4
Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment
Time frame: Treatment week 8
Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment
Time frame: Treatment week 4
Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment
Time frame: Treatment week 8
Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment
Time frame: Treatment week 12
Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up
Time frame: Follow-up week 14

Results and safety

Results posted to the registry on 29 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Posaconazole	62	47

Primary outcome: Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment

Time frame: Treatment week 12. Number. Unit: Participants

Measure	Posaconazole n = 59
Complete response	6
Partial response	32
Stable	11
Failure	10

Population analysed: Pool of participants were from the Full Analysis Set (FAS): included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
POSACONAZOLE	5 of 62 (8.1%)	40 of 62 (64.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22324990Huang X, Wang F, Chen Y, Liu T, Wang J, Hu J, Jie J, Chen F, Wang S, Shen Z, Yu L, Yu K, Liang Y. A multicenter, open-label study of posaconazole oral suspension in the treatment of invasive fungal infections in patients refractory to or intolerant of first-line therapy. Future Microbiol. 2012 Feb;7(2):201-9. doi: 10.2217/fmb.11.158.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Posaconazole in people with Fungal Infection, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment (time frame: Treatment week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00811642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.