fluconazole and Asymptomatic Colonization studies

Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.
fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis.

Research Excerpts

Excerpt	Relevance	Reference
"We retrospectively analyzed the medical records and radiographic findings of 10 healthy subjects with isolated pulmonary cryptococcosis diagnosed incidentally and treated with oral fluconazole."	7.77	Treatment of asymptomatic pulmonary cryptococcosis in immunocompetent hosts with oral fluconazole. ( Choi, KH; Chung, CR; Han, HJ; Kim, SR; Lee, MH; Lee, YC; Min, KH; Park, SJ, 2011)
"We retrospectively analyzed the medical records and radiographic findings of 10 healthy subjects with isolated pulmonary cryptococcosis diagnosed incidentally and treated with oral fluconazole."	3.77	Treatment of asymptomatic pulmonary cryptococcosis in immunocompetent hosts with oral fluconazole. ( Choi, KH; Chung, CR; Han, HJ; Kim, SR; Lee, MH; Lee, YC; Min, KH; Park, SJ, 2011)
"Sertraline was associated with excess SAEs of psychosis."	2.94	Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial. ( Bangdiwala, AS; Boulware, DR; Hullsiek, KH; Kirumira, P; Meya, DB; Nalintya, E; Naluyima, R; Namanda, S; Nikweri, Y; Rajasingham, R; Rutakingirwa, MK; Skipper, CP; Turya, F, 2020)

Research

Studies (2)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

6 Month Meningitis-free Survival

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (50.00)	24.3611
2020's	1 (50.00)	2.80

Authors	Studies
Boulware, DR	1
Nalintya, E	1
Rajasingham, R	1
Kirumira, P	1
Naluyima, R	1
Turya, F	1
Namanda, S	1
Rutakingirwa, MK	1
Skipper, CP	1
Nikweri, Y	1
Hullsiek, KH	1
Bangdiwala, AS	1
Meya, DB	1
Choi, KH	1
Park, SJ	1
Min, KH	1
Kim, SR	1
Lee, MH	1
Chung, CR	1
Han, HJ	1
Lee, YC	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Cryptococcal Antigen Screening Plus Sertraline[NCT03002012]	Phase 3	22 participants (Actual)	Interventional	2017-11-15	Terminated (stopped due to SAEs with n=1 serotonin syndrome, n=2 SAEs after sertraline interruption.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"Cryptococcal meningitis free survival with retention-in-care through 6 months~Those who die of any cause are failures~Those developing symptomatic cryptococcal meningitis are failures~Those lost to follow up and unable to be tracked are considered failures" (NCT03002012)
Timeframe: 6 months

6-month Survival

All-Cause Premature Study Drug/Placebo Discontinuation

Intervention	Participants (Count of Participants)
Sertraline	11
Control	9

Intervention	Participants (Count of Participants)
Sertraline	11
Control	10

Number of participants whose study drug/placebo use was halted prematurely due to any cause through 6 months (NCT03002012)
Timeframe: 6 months

Cumulative Incidence of Symptomatic Cryptococcal Meningoencephalitis

Intervention	Participants (Count of Participants)
Sertraline	1
Control	0

Cumulative incidence of symptomatic cryptococcal meningoencephalitis through 6 months (NCT03002012)
Timeframe: 6 months

Number of Clinical Adverse Events (Grade 3-5)

Intervention	meningitis events (Number)
Sertraline	0
Control	1

Number of Clinical Adverse Events by Division of AIDS (DAIDS) Scale for Grade 3-5 events through 6 months (NCT03002012)
Timeframe: 6 months

Number of Laboratory Grade 3-5 Adverse Events

Intervention	number of grade 3-5 adverse events (Number)
Sertraline	4
Control	2

Number of Laboratory Grade 3-5 Adverse Events through 6 months as per the Division of AIDS (DAIDS) grading scale (NCT03002012)
Timeframe: 6 months

Adherence to Study Drug

Intervention	number of grade 3-5 adverse events (Number)
Sertraline	4
Control	1

Participants' percent adherence to study drug regiment by pharmacy medication counts, representing the percent of the total prescribed medication taken by participants. (NCT03002012)
Timeframe: 12 weeks

Prevalence of Depression by Patient Health Questionnaire (PHQ-9) Over Time

Intervention	Percent of total prescribed medication t (Median)
	Week 2	Week 4	Week 8	Week 12
Control	100	100	100	100
Sertraline	100	100	97	89

Prevalence of depression by Patient Health Questionnaire (PHQ-9) over 6 months as measured at baseline, 4 weeks, 8 weeks, and 12 weeks. The PHQ-9 is a 9-item instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Items are rated on a scale from 0 (not at all) to 3 (nearly every day). Total score is a sum of 9 item scores (Range 0-27). Greater scores indicate greater depressive symptoms. PHQ-9 scores of: 0-4 Minimal/No depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderate severe depression; 20-27 Severe depression. This endpoint reports the median (interquartile range) of the PHQ-9 scores over time. (NCT03002012)
Timeframe: 12 weeks

fluconazole and Asymptomatic Colonization