Who is sponsoring NCT03098394?

NCT03098394 is sponsored by University of Maryland, Baltimore.

What drugs are being tested in NCT03098394?

Interventions in NCT03098394: Cepheid Xpert CT/NG Rapid Turnaround Test, Polymerase chain reaction (PCR).

What condition does NCT03098394 study?

NCT03098394 studies Sexually Transmitted Infection, Gonorrhea Female, Chlamydia Females.

Is NCT03098394 still recruiting?

NCT03098394 is currently terminated. Last updated 31 August 2023.

Are results published for NCT03098394?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-08-31 · How we verify

NCT03098394

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections

Terminated NA Results posted Last updated 31 August 2023

What this trial tests

NA trial testing Cepheid Xpert CT/NG Rapid Turnaround Test in Sexually Transmitted Infection in 64 participants. Terminated before completion.

Timeline

24 September 2018

Primary endpoint
25 March 2022

20 June 2023

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	diagnostic
Enrollment	64
Start date	24 September 2018
Primary completion	25 March 2022
Estimated completion	20 June 2023
Sites	1 location across United States

Drugs / interventions tested

Cepheid Xpert CT/NG Rapid Turnaround Test
Polymerase chain reaction (PCR)

Conditions studied

Sexually Transmitted Infection — all drugs for Sexually Transmitted Infection →
Gonorrhea Female — all drugs for Gonorrhea Female →
Chlamydia Females — all drugs for Chlamydia Females →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 65, female only, with Sexually Transmitted Infection or Gonorrhea Female. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Treated With Antibiotics Primary · 7 days

Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.

Group	Value	95% CI
Rapid Turnaround Test	4
Usual Care	10

Length of Stay (Minutes) Secondary · 7 days

Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.

Group	Value	95% CI
Rapid Turnaround Test	200.6896552	± 48.12936692
Usual Care	129.6060606	± 60.9717862

Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed. Secondary · 7 days

Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in subjects that have both performed (Experimental Group).

Group	Value	95% CI
Subjects Who Received Both RTAT and Usual Care Tests	92.307

Average Score for Patient Satisfaction With Provider Explanation. Secondary · 7 days

Evaluate patient satisfaction with provider's explanations for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their provider's explanations on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."

Group	Value	95% CI
Rapid Turnaround Test	3.346153846	± 0.745241314
Usual Care	3.24137931	± 0.872401137

Average Score for Patient Satisfaction With Treatment Effectiveness. Secondary · 7 days

Evaluate patient satisfaction with treatment effectiveness for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their treatment effectiveness on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."

Group	Value	95% CI
Rapid Turnaround Test	3.153846154	± 0.731699812
Usual Care	3.206896552	± 0.726012118

Average Score for Patient Satisfaction With Overall Experience. Secondary · 7 days

Evaluate patient satisfaction with overall experience during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."

Group	Value	95% CI
Rapid Turnaround Test	3.346153846	± 0.561591146
Usual Care	3.275862069	± 0.797162455

Number of Patients That Required Follow-up Care Within 7 Days Secondary · 7 days

Compare need for additional healthcare utilization between the groups.

Group	Value	95% CI
Rapid Turnaround Test	4
Usual Care	1

Average Score for Patient Satisfaction With Wait Times During Visit. Secondary · 7 days

Evaluate patient satisfaction with wait times during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."

Group	Value	95% CI
Rapid Turnaround Test	3.038461538	± 0.999230473
Usual Care	2.931034483	± 0.923155864

Sponsor's own description

The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Sexually Transmitted Infection

Currently open trials in the same condition.

NCT05244967 — Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility · recruiting
NCT01088542 — The Community Youth Development Study: A Test of Communities That Care · NA · active not recruiting

Other University of Maryland, Baltimore trials

Trials by the same sponsor.

NCT07537413 — Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia · Phase 4 · not yet recruiting
NCT07221799 — OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis · Phase 1 · not yet recruiting
NCT07094672 — Development of an Opioid Withdrawal Clinical Outcome Assessment · not yet recruiting
NCT06583239 — Hub-Based Engagement Navigator Service to Reduce CSC Disengagement · NA · not yet recruiting
NCT07536412 — Decision Aid Efficacy in Low Risk Thyroid Cancer · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03098394 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
Last refreshed: 31 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03098394.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing