Trial Outcomes & Findings for Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection (NCT NCT01562132)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	5FC Plus Fluconazole Combination therapy with oral fluconazole and flucytosine Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily	Fluconazole Alone Fluconazole monotherapy Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Fluconazole in Combination With Flucytosine for the Treatment of Early Cryptococcal Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5FC Plus Fluconazole n=3 Participants Combination therapy with oral fluconazole and flucytosine Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily	Fluconazole Alone n=3 Participants Fluconazole monotherapy Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily	Total n=6 Participants Total of all reporting groups
Age, Continuous	36 years n=5 Participants	31 years n=7 Participants	33.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Kenya	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
CD4+ T-cell Count	22 cells/microliter n=5 Participants	13 cells/microliter n=7 Participants	17 cells/microliter n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	5FC Plus Fluconazole n=3 Participants Combination therapy with oral fluconazole and flucytosine Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily	Fluconazole Alone n=3 Participants Fluconazole monotherapy Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
Number of Participants Alive at 12 Weeks	2 participants	2 participants

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Individuals who develop clinical meningitis without evidence of fungal, bacterial, or parasitic (e.g. malaria) organisms in the cerebrospinal fluid. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND * At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness.

Outcome measures

Outcome data not reported

Adverse Events

5FC Plus Fluconazole

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Fluconazole Alone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	5FC Plus Fluconazole n=3 participants at risk Combination therapy with oral fluconazole and flucytosine Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily	Fluconazole Alone n=3 participants at risk Fluconazole monotherapy Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
Blood and lymphatic system disorders Neutropenia	66.7% 2/3 • Number of events 2	33.3% 1/3 • Number of events 1
General disorders Unintentional Weight Loss	33.3% 1/3 • Number of events 1	0.00% 0/3
Gastrointestinal disorders Nausea	0.00% 0/3	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Vomiting	0.00% 0/3	33.3% 1/3 • Number of events 1

Additional Information

Dr. Ana-Claire Meyer

Yale University

Phone: 203-737-8372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60