Trial Outcomes & Findings for Evaluation of Immediate v. Delayed CT/NG Test for Treatment in the ED (NCT NCT01989130)

Results Overview

Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

one year

Results posted on

2019-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Real-time Results With Cepheid Xpert CT/NG Test Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test	Batched Results With Roche AMPLICOR CT/NG Test Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Roche AMPLICOR CT/NG
Overall Study STARTED	43	27
Overall Study COMPLETED	43	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Immediate v. Delayed CT/NG Test for Treatment in the ED

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real-time Results With Cepheid Xpert CT/NG Test n=43 Participants Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test	Batched Results With Roche AMPLICOR CT/NG Test n=27 Participants Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Roche AMPLICOR CT/NG	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=93 Participants	26 Participants n=4 Participants	67 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	27 Participants n=93 Participants	16 Participants n=4 Participants	43 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	11 Participants n=4 Participants	27 Participants n=27 Participants
Region of Enrollment United States	43 participants n=93 Participants	27 participants n=4 Participants	70 participants n=27 Participants

PRIMARY outcome

Timeframe: one year

Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups

Outcome measures

Outcome measures
Measure	Real-time Results With Cepheid Xpert CT/NG Test n=43 Participants Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test	Batched Results With Roche AMPLICOR CT/NG Test n=27 Participants Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Roche AMPLICOR CT/NG
Percentage of Participants Prescribed Antibiotic Treatment	7.1 percentage of 70 participants	5.7 percentage of 70 participants

PRIMARY outcome

Timeframe: one year

Population: Analysis included patients that responded to the 7-10 day follow-up phone call.

Number of participants with visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment

Outcome measures

Outcome measures
Measure	Real-time Results With Cepheid Xpert CT/NG Test n=20 Participants Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test	Batched Results With Roche AMPLICOR CT/NG Test n=17 Participants Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Roche AMPLICOR CT/NG
Health Utilization Subsequent hospitalization	1 Participants	1 Participants
Health Utilization subsequent office visit	5 Participants	2 Participants
Health Utilization new prescription drugs	3 Participants	0 Participants

PRIMARY outcome

Timeframe: one year

Population: This outcome measure was not measured, as insurance coverage for hospital and physician charges was unavailable.

To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: one year

Population: Analysis of patients who completed the 7-10 day follow-up phone call

Number of patients that report having no symptoms 7 to 10 days after initial encounter

Outcome measures

Outcome measures
Measure	Real-time Results With Cepheid Xpert CT/NG Test n=20 Participants Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test	Batched Results With Roche AMPLICOR CT/NG Test n=17 Participants Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Roche AMPLICOR CT/NG
Resolution of Symptoms	17 Participants	10 Participants

Adverse Events

Real-time Results With Cepheid Xpert CT/NG Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Batched Results With Roche AMPLICOR CT/NG Test

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

Larissa May, MD

University of California-Davis

Phone: 916-736-5010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place