Deep MycosisDREAMNCT01680458

Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

An observational study of Deep Mycosis, run by Pfizer.

Completed

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

Trial summary

To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice. Read more about this study

Who is it for?: Ages 0 to 6 years
Conditions the study is for: Deep Mycosis
What is being tested?: Fluconazole
How many people: 30 participants
Where: No sites listed yet
Study dates: Nov 2012to Oct 2014
Phase: Observational
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 0 to 6 years
All sexes
No healthy volunteers
Child

Study population: The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).

Who may be able to join

Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.

Who cannot join

Subject of seven years or more who have been prescribed fluconazole.

About this study

Official title: Special Investigation Of Fluconazole For Pediatric Subjects

To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.

Conditions: Deep Mycosis
Being tested: Fluconazole
Keywords: antifungal treatment, prophylaxis, administration, Japanese, infants, fluconazole, Diflucan, Regulatory Post Marketing Commitment Plan.

What participants receive

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

FluconazoleDrug
Also called Diflucan
Candidiasis infection: The recommended dosage in children is 3 mg/kg once daily.
Cryptococcal infection: The recommended dosage in children is 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy.
Prophylactic administration for deep mycosis on Hematopoietic stem cell transplantation: The recommended dosage in children is 12 mg/kg once daily.
Absolute doses exceeding 600 mg/day are not recommended.

Study groups in NCT01680458
Study group	Role	What they receive
fluconazole		Infant Subjects who are treated with fluconazole Receives: Drug: Fluconazole

What is being measured

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

Number of Participants With Treatment-Related Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Measured: MAX 13 Weeks
Number of Participants With Treatment-Related Serious Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Measured: MAX 13 Weeks
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Measured: MAX 13 Weeks

Secondary outcomes (3)

Clinical Efficacy Rate
Clinical effect of treatment was evaluated based on the clinical course excluding mycological effect as follows: (1) effective, (2) ineffective, or (3) unevaluable. Clinical efficacy rate was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Clinical efficacy rate (%) = (Number of responders in evaluation of clinical effect) / (Number of participants available for clinical efficacy evaluation) x 100.
Measured: MAX 13 Weeks
Fungi Eradication Rate
Mycological effect of treatment was evaluated as follows: (1) eradicated; the causative fungi detected from the lesion before treatment became undetectable, (2) presumably eradicated; the lesion was improved and sampling of causative fungi became impossible, (3) decreased; the causative fungi were decreased, (4) unchanged; no change was observed in the causative fungi, (5) increased; the causative fungi were increased (including microbial substitution), and (6) indeterminate; the clinical follow-up was inadequate, causative fungi were undetectable, or mycological test was not performed. Fungi eradication rate was calculated as follows. Fungi eradication rate (%) = (Number of participants evaluated as "eradicated" or "presumably eradicated") / (Number of participants available for mycological efficacy evaluation) x 100
Measured: MAX 13 Weeks
Onset Rate of Deep Mycosis
Efficacy of deep mycosis prophylaxis was evaluated by the presence or absence of deep mycosis onset during the observation period. Onset rate of deep mycosis was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Onset rate of deep mycosis (%) = (Number of participants with deep mycosis onset by target fungi) / (Number of participants available for prophylactic efficacy evaluation) x 100.
Measured: MAX 13 Weeks

Timeline

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

Nov 2012Oct 2014

First posted7 Sep 2012 (estimated)
Study startNov 2012
Primary completionOct 2014
Study completionOct 2014

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.
Other trials for Deep MycosisStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01680458
Sponsor's protocol ID: A0561022
Acronym: DREAM
Status last verified: Jul 2021
First submitted: 4 Sep 2012
Last updated: 19 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Investigation Of Fluconazole For Pediatric Subjects
ClinicalTrials.gov ID: NCT01680458
Acronym / sponsor ID: DREAM / A0561022
Conditions: Deep Mycosis
Keywords: antifungal treatment, prophylaxis, administration, Japanese, infants, fluconazole, Diflucan, Regulatory Post Marketing Commitment Plan.
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 7 Sep 2012 (estimated)
Results: Posted 9 Dec 2015

Clinical summary

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

To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
fluconazole	–	Drug: FluconazoleInfant Subjects who are treated with fluconazole

Who may qualify

Ages: 0 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).

Key inclusion criteria (1 listed)

Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.

Key exclusion criteria (1 listed)

Subject of seven years or more who have been prescribed fluconazole.

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
FluconazoleAlso: DiflucanCandidiasis infection: The recommended dosage in children is 3 mg/kg once daily. Cryptococcal infection: The recommended dosage in children is 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy. Prophylactic administration for deep mycosis on Hematopoietic stem cell transplantation: The recommended dosage in children is 12 mg/kg once daily. Absolute doses exceeding 600 mg/day are not recommended.	Drug	fluconazole

Primary outcome

Number of Participants With Treatment-Related Adverse Events
Time frame: MAX 13 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Number of Participants With Treatment-Related Serious Adverse Events
Time frame: MAX 13 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Time frame: MAX 13 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).

3 secondary outcomes

Clinical Efficacy Rate
Time frame: MAX 13 Weeks
Fungi Eradication Rate
Time frame: MAX 13 Weeks
Onset Rate of Deep Mycosis
Time frame: MAX 13 Weeks

Results and safety

Results posted to the registry on 9 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluconazole	30	27

Primary outcome: Number of Participants With Treatment-Related Adverse Events

Time frame: MAX 13 Weeks. Number. Unit: Participants

Measure	Fluconazole n = 27
Value	1 (0.00 to 13.72)

Population analysed: SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.

Primary outcome: Number of Participants With Treatment-Related Serious Adverse Events

Time frame: MAX 13 Weeks. Number. Unit: Participants

Measure	Fluconazole n = 27
Value	0 (0.00 to 13.72)

Population analysed: SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.

Primary outcome: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

Time frame: MAX 13 Weeks. Number. Unit: Participants

Measure	Fluconazole n = 27
Value	0 (0.00 to 13.72)

Population analysed: SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluconazole	2 of 27 (7.4%)	9 of 27 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Deep Mycosis, run by Pfizer.

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 1 inclusion and 1 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 19 Jul 2021. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2015). 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 With Treatment-Related Adverse Events (time frame: MAX 13 Weeks). The study lists 3 primary outcomes in all. 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 NCT01680458.

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 19 Jul 2021.