Trial Outcomes & Findings for Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment (NCT NCT00934934)

Results Overview

Overall recruitment rate per site

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

32 months

Results posted on

2021-02-01

Participant Flow

One pt was mistakenly randomized to intervention without Candida, so was moved to observational group prior to starting treatment

Participant milestones

Participant milestones
Measure	Placebo Saline will serve as the placebo solution since the active comparator is clear and colourless. Normal Saline: Normal Saline	Antifungal Patient will receive a dose daily for a total of 14 days anidulafungin: TBA
Overall Study STARTED	30	31
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=29 Participants Saline will serve as the placebo solution since the active comparator is clear and colourless. Normal Saline: Normal Saline	Antifungal n=31 Participants Patient will receive a dose daily for a total of 14 days anidulafungin: TBA	Total n=60 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 13.8 • n=5 Participants	57.6 years STANDARD_DEVIATION 17.1 • n=7 Participants	60.3 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment Canada	29 participants n=5 Participants	31 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 32 months

Population: This outcome measure was pre-specified to be for overall participants not by group. It was a reflection of how recruitment went for this protocol overall not by group.

Overall recruitment rate per site

Outcome measures

Outcome measures
Measure	Overall n=5 sites	Antifungal
Overall Recruitment Rate	0.6 participants per site /month	—

SECONDARY outcome

Timeframe: 28 days

Measure of the duration of participant stay in the ICU

Outcome measures

Outcome measures
Measure	Overall n=29 Participants	Antifungal n=31 Participants
Duration of Stay in ICU	11.5 days Interval 8.0 to 20.0	13 days Interval 8.0 to 28.0

SECONDARY outcome

Timeframe: 28 days

Number of days in ICU free of ventilation

Outcome measures

Outcome measures
Measure	Overall n=29 Participants	Antifungal n=31 Participants
Ventilator Free Days	8 days Interval 6.0 to 11.0	9 days Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: 28 days

Number of days free of ICU

Outcome measures

Outcome measures
Measure	Overall n=29 Participants	Antifungal n=31 Participants
ICU Free Days	14 days Interval 0.0 to 17.0	4 days Interval 0.0 to 17.0

SECONDARY outcome

Timeframe: 28 days

Number of days free of antibiotic use within the first 28 days

Outcome measures

Outcome measures
Measure	Overall n=29 Participants	Antifungal n=31 Participants
Antibiotic Free Days 28-day Post Randomization	16 days Interval 12.0 to 20.0	10 days Interval 0.0 to 20.0

SECONDARY outcome

Timeframe: 90 days

Measure of the duration of the participant's hospital stay

Outcome measures

Outcome measures
Measure	Overall n=29 Participants	Antifungal n=31 Participants
Hospital Length of Stay	29 days Interval 17.0 to 38.0	28 days Interval 18.0 to 46.0

SECONDARY outcome

Timeframe: post randomization

Sequential organ failure assessment. 0-24 The higher the number the more severe organ failure

Outcome measures

Outcome measures
Measure	Overall n=29 Participants	Antifungal n=31 Participants
(SOFA) Post Randomization	5.9 score on a scale Standard Deviation 3.3	5.9 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Overall n=56 Participants	Antifungal n=21 Participants
Sequential Procalcitonin	3.0 ng/ml Standard Deviation 8.8	22.5 ng/ml Standard Deviation 89.4

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Overall n=56 Participants	Antifungal n=21 Participants
C-reactive Protein	133 mg/l Standard Deviation 115	145.7 mg/l Standard Deviation 104

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Overall n=56 Participants	Antifungal n=21 Participants
Interleukin-6	97.5 pg/ml Standard Deviation 183	3 pg/ml Standard Deviation 10.3

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Overall n=56 Participants	Antifungal n=21 Participants
B-glucan Levels	116 pg/ml Standard Deviation 171	129.1 pg/ml Standard Deviation 190.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Antifungal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Daren Heyland

CERU Queens University

Phone: 403-915-5573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place