DREAM: Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01680458
• Collaborator: (none)
• Enrollment: 30
• Duration (Months): 23

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Deep Mycosis	Drug: Fluconazole

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Special Investigation Of Fluconazole For Pediatric Subjects
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

fluconazole Infant Subjects who are treated with fluconazole

Drug: Fluconazole; 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.; Other Names: Diflucan

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [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.).

2. Number of Participants With Treatment-Related Serious Adverse Events [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.).

3. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [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.).

Secondary Outcome Measures

1. Clinical Efficacy Rate [MAX 13 Weeks]

   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.

2. Fungi Eradication Rate [MAX 13 Weeks]

   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

3. Onset Rate of Deep Mycosis [MAX 13 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01680458
• Other Study ID Numbers: A0561022
• First Posted: Sep 7, 2012
• Last Update Posted: Jul 19, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Pfizer: antifungal treatment; prophylaxis; administration; Japanese; infants; fluconazole; Diflucan; Regulatory Post Marketing Commitment Plan.
• Additional relevant MeSH terms: Mycoses; Fluconazole

Study Results

Participant Flow

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Period Title: Overall Study
STARTED	30
COMPLETED	27
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Participants	27
Age, Customized (Number) [Number]
Less than 4 weeks	1 3.7%
4 weeks to less than 1 year	4 14.8%
1 to less than 7 years	22 81.5%
Sex: Female, Male (Count of Participants)
Female	18 66.7%
Male	9 33.3%
Reason for administration, Treatment/Prophylaxis (Number) [Number]
Treatment	2 7.4%
Prophylaxis	25 92.6%

Outcome Measures

1. Secondary Outcome

Title	Clinical Efficacy Rate
Description	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.
Time Frame	MAX 13 Weeks

Outcome Measure Data

Analysis Population Description

Efficacy analysis set for treatment comprised of participants in safety analysis set (SAS) who had started to receive fluconazole for the treatment and had been evaluated for the clinical effect.

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Measure Participants	2
Number (95% Confidence Interval) [Percentage of participants]	100 370.4%

2. Secondary Outcome

Title	Fungi Eradication Rate
Description	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
Time Frame	MAX 13 Weeks

Outcome Measure Data

Analysis Population Description

Mycological analysis set for treatment comprised of participants in SAS with the final diagnosis of deep mycosis, who had started to receive fluconazole for the treatment and had been evaluated for the mycological effect.

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Measure Participants	2
Number [Percentage of participants]	0 0%

3. Secondary Outcome

Title	Onset Rate of Deep Mycosis
Description	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.
Time Frame	MAX 13 Weeks

Outcome Measure Data

Analysis Population Description

Efficacy analysis set for prophylaxis comprised of participants in SAS who had started to receive fluconazole for the prophylaxis and had been evaluated for the presence or absence of deep mycosis onset.

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Measure Participants	25
Number (95% Confidence Interval) [Percentage of participants]	0 0%

4. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	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.).
Time Frame	MAX 13 Weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Measure Participants	27
Number [Participants]	1 3.7%

5. Primary Outcome

Title	Number of Participants With Treatment-Related Serious Adverse Events
Description	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.).
Time Frame	MAX 13 Weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Measure Participants	27
Number [Participants]	0 0%

6. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Description	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.).
Time Frame	MAX 13 Weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Measure Participants	27
Number [Participants]	0 0%

Adverse Events

Adverse Event Reporting Description	The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Fluconazole
Arm/Group Description	Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
All Cause Mortality
	Fluconazole
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fluconazole
	Affected / at Risk (%)	# Events
Total	2/27 (7.4%)
Blood and lymphatic system disorders
Febrile neutropenia	2/27 (7.4%)	2
Infections and infestations
Skin infection	1/27 (3.7%)	1
Other (Not Including Serious) Adverse Events
	Fluconazole
	Affected / at Risk (%)	# Events
Total	9/27 (33.3%)
Blood and lymphatic system disorders
Febrile neutropenia	4/27 (14.8%)	4
Anaemia	1/27 (3.7%)	1
Gastrointestinal disorders
Nausea	1/27 (3.7%)	1
Diarrhoea	1/27 (3.7%)	1
Oral disorder	2/27 (7.4%)	2
General disorders
Catheter site erythema	1/27 (3.7%)	1
Inflammation	1/27 (3.7%)	1
Mucous membrane disorder	1/27 (3.7%)	1
Hepatobiliary disorders
Hepatic function abnormal	1/27 (3.7%)	1
Liver disorder	2/27 (7.4%)	2
Immune system disorders
Graft versus host disease	1/27 (3.7%)	1
Investigations
Platelet count decreased	1/27 (3.7%)	1
Metabolism and nutrition disorders
Feeding disorder neonatal	1/27 (3.7%)	1
Hypoalbuminaemia	1/27 (3.7%)	1
Vascular disorders
Hypertension	1/27 (3.7%)	1
Capillary leak syndrome	1/27 (3.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.