N/A N=70 Randomized Diagnostic

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

Reproductive Tract Infections

Bottom Line

View on ClinicalTrials.gov: NCT01989130 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Percentage of Participants Prescribed Antibiotic Treatment — 7.1; 5.7 percentage of 70 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Roche AMPLICOR CT/NG (Device); Cepheid Xpert CT/NG Test (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: George Washington University
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Prescribed Antibiotic Treatment	7.1; 5.7	—
PRIMARY Health Utilization	1; 1; 5; 2; 3; 0	—
PRIMARY Healthcare Cost	—	—
PRIMARY Resolution of Symptoms	17; 10	—

Summary

The purpose of this study is to determine if immediate availability of GeneXpert® CT/NG test results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia and to assess changes in clinician management decisions with real-time test results.

Eligibility Criteria

Inclusion Criteria

greater than 18 years
clinical suspicion of CT/NG
able to give informed consent
willingness to wait for test result

Exclusion Criteria

less than 18 years
pregnancy
prisoners
unable to give informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01989130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.