Trial Outcomes & Findings for Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication (NCT NCT01680458)

Last Updated: 2021-07-19

Results Overview

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.).

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

MAX 13 Weeks

Results posted on

2021-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Fluconazole Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluconazole Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Overall Study Protocol Violation	3

Baseline Characteristics

Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluconazole n=27 Participants Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Age, Customized Less than 4 weeks	1 Participants n=5 Participants
Age, Customized 4 weeks to less than 1 year	4 Participants n=5 Participants
Age, Customized 1 to less than 7 years	22 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Reason for administration, Treatment/Prophylaxis Treatment	2 Participants n=5 Participants
Reason for administration, Treatment/Prophylaxis Prophylaxis	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: MAX 13 Weeks

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

Outcome measures

Outcome measures
Measure	Fluconazole n=27 Participants Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Number of Participants With Treatment-Related Adverse Events	1 Participants Interval 0.0 to 13.72

PRIMARY outcome

Timeframe: MAX 13 Weeks

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

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.).

Outcome measures

Outcome measures
Measure	Fluconazole n=27 Participants Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Number of Participants With Treatment-Related Serious Adverse Events	0 Participants Interval 0.0 to 13.72

PRIMARY outcome

Timeframe: MAX 13 Weeks

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

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.).

Outcome measures

Outcome measures
Measure	Fluconazole n=27 Participants Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	0 Participants Interval 0.0 to 13.72

SECONDARY outcome

Timeframe: MAX 13 Weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Fluconazole n=2 Participants Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Clinical Efficacy Rate	100 Percentage of participants Interval 2.5 to 100.0

SECONDARY outcome

Timeframe: MAX 13 Weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Fluconazole n=2 Participants Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Fungi Eradication Rate	0 Percentage of participants Interval 2.5 to 100.0

SECONDARY outcome

Timeframe: MAX 13 Weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Fluconazole n=25 Participants Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Onset Rate of Deep Mycosis	0 Percentage of participants Interval 0.0 to 13.72

Adverse Events

Fluconazole

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluconazole n=27 participants at risk Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Infections and infestations Skin infection	3.7% 1/27 • Number of events 1 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.
Blood and lymphatic system disorders Febrile neutropenia	7.4% 2/27 • Number of events 2 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.

Other adverse events

Other adverse events
Measure	Fluconazole n=27 participants at risk Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
Blood and lymphatic system disorders Febrile neutropenia	14.8% 4/27 • Number of events 4 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.
Blood and lymphatic system disorders Anaemia	3.7% 1/27 • Number of events 1 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.
Immune system disorders Graft versus host disease	3.7% 1/27 • Number of events 1 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.
Metabolism and nutrition disorders Feeding disorder neonatal	3.7% 1/27 • Number of events 1 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.
Metabolism and nutrition disorders Hypoalbuminaemia	3.7% 1/27 • Number of events 1 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.
Vascular disorders Hypertension	3.7% 1/27 • Number of events 1 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.
Vascular disorders Capillary leak syndrome	3.7% 1/27 • Number of events 1 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.
Gastrointestinal disorders Nausea	3.7% 1/27 • Number of events 1 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.
Gastrointestinal disorders Diarrhoea	3.7% 1/27 • Number of events 1 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.
Gastrointestinal disorders Oral disorder	7.4% 2/27 • Number of events 2 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.
Hepatobiliary disorders Hepatic function abnormal	3.7% 1/27 • Number of events 1 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.
Hepatobiliary disorders Liver disorder	7.4% 2/27 • Number of events 2 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.
General disorders Catheter site erythema	3.7% 1/27 • Number of events 1 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.
General disorders Inflammation	3.7% 1/27 • Number of events 1 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.
General disorders Mucous membrane disorder	3.7% 1/27 • Number of events 1 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.
Investigations Platelet count decreased	3.7% 1/27 • Number of events 1 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER