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

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ClinicalTrials.gov Identifier: NCT01680458
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : December 9, 2015
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Deep Mycosis
Intervention Drug: Fluconazole
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluconazole
Hide 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
Reason Not Completed
Protocol Violation             3
Arm/Group Title Fluconazole
Hide Arm/Group Description Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
In total, 30 participants were enrolled in the study. Of the 30 participants, a total of 3 participants were excluded from the baseline analysis because of protocol violation.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
Less than 4 weeks 1
4 weeks to less than 1 year 4
1 to less than 7 years 22
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
18
  66.7%
Male
9
  33.3%
Reason for administration, Treatment/Prophylaxis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
Treatment 2
Prophylaxis 25
1.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
1
2.Primary Outcome
Title Number of Participants With Treatment-Related Serious Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
0
3.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
0
4.Secondary Outcome
Title Clinical Efficacy Rate
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Number of Participants Analyzed 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(2.50 to 100.00)
5.Secondary Outcome
Title Fungi Eradication Rate
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Percentage of participants
0
6.Secondary Outcome
Title Onset Rate of Deep Mycosis
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0.00 to 13.72)
Time Frame [Not Specified]
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
Hide 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 (%)
Total   --/--    
Hide Serious Adverse Events
Fluconazole
Affected / at Risk (%) # Events
Total   2/27 (7.41%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  2/27 (7.41%)  2
Infections and infestations   
Skin infection * 1  1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluconazole
Affected / at Risk (%) # Events
Total   9/27 (33.33%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  4/27 (14.81%)  4
Anaemia * 1  1/27 (3.70%)  1
Gastrointestinal disorders   
Nausea * 1  1/27 (3.70%)  1
Diarrhoea * 1  1/27 (3.70%)  1
Oral disorder * 1  2/27 (7.41%)  2
General disorders   
Catheter site erythema * 1  1/27 (3.70%)  1
Inflammation * 1  1/27 (3.70%)  1
Mucous membrane disorder * 1  1/27 (3.70%)  1
Hepatobiliary disorders   
Hepatic function abnormal * 1  1/27 (3.70%)  1
Liver disorder * 1  2/27 (7.41%)  2
Immune system disorders   
Graft versus host disease * 1  1/27 (3.70%)  1
Investigations   
Platelet count decreased * 1  1/27 (3.70%)  1
Metabolism and nutrition disorders   
Feeding disorder neonatal * 1  1/27 (3.70%)  1
Hypoalbuminaemia * 1  1/27 (3.70%)  1
Vascular disorders   
Hypertension * 1  1/27 (3.70%)  1
Capillary leak syndrome * 1  1/27 (3.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
ClinicalTrials.gov Identifier: NCT01680458    
Other Study ID Numbers: A0561022
First Submitted: September 4, 2012
First Posted: September 7, 2012
Results First Submitted: November 4, 2015
Results First Posted: December 9, 2015
Last Update Posted: January 28, 2021