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

NCT03098394 | Terminated Results DMC FDA Device

• 1 other identifier: HP-00072766
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sexually Transmitted Infection; Gonorrhea Female; Chlamydia Females

Keywords

Rapid turnaround test; RTAT; Gonorrhea; Chlamydia; STI

Outcome Measures

Primary Outcomes (1)

• Number of Participants Treated With Antibiotics

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

  7 days

Secondary Outcomes (8)

• Length of Stay (Minutes)

  7 days

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

  7 days

• Healthcare Costs.

  7 days

• Average Score for Patient Satisfaction With Provider Explanation.

  7 days

• Average Score for Patient Satisfaction With Treatment Effectiveness.

  7 days

Study Arms (2)

Rapid Turnaround Test

EXPERIMENTAL

Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.

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

Usual Care

ACTIVE COMPARATOR

Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.

Device: Polymerase chain reaction (PCR)

Interventions

Cepheid Xpert CT/NG Rapid Turnaround Test DEVICE

This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.

Also known as: GeneXpert

Rapid Turnaround Test

Polymerase chain reaction (PCR) DEVICE

This is the standard of care for diagnosis of a suspected sexually transmitted infection.

Also known as: PCR

Rapid Turnaround Test; Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participant eligibility is not based on self-representation of gender identity. All participants in this study will receive a pelvic exam in the emergency department as well as a cervical swab for diagnostic testing.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients age 18-55
• Signs or symptoms consistent with sexually transmitted infection
• Medical provider willing to consider the result of the rapid turnaround test in decision to treat for gonorrhea/chlamydia
• Must have a urine specimen obtained and a pelvic exam performed as part of the anticipated standard of care evaluation
• Provides informed consent

You may not qualify if:

• Signs of systemic infection
• Patient in whom the provider is unwilling to consider the result of the rapid turnaround test
• Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3 months
• Patients undergoing evaluation for sexual assault
• Patients that are known to be pregnant or express concern that they may be pregnant
• Incarcerated patients
• Students/Employees of the facility

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location

Related Publications (6)

• Brook G. The performance of non-NAAT point-of-care (POC) tests and rapid NAAT tests for chlamydia and gonorrhoea infections. An assessment of currently available assays. Sex Transm Infect. 2015 Dec;91(8):539-44. doi: 10.1136/sextrans-2014-051997. Epub 2015 May 2.

  PMID: 25935930 BACKGROUND

• Gaydos CA. Review of use of a new rapid real-time PCR, the Cepheid GeneXpert(R) (Xpert) CT/NG assay, for Chlamydia trachomatis and Neisseria gonorrhoeae: results for patients while in a clinical setting. Expert Rev Mol Diagn. 2014 Mar;14(2):135-7. doi: 10.1586/14737159.2014.871495. Epub 2014 Jan 23.

  PMID: 24450867 BACKGROUND

• Gaydos CA, Van Der Pol B, Jett-Goheen M, Barnes M, Quinn N, Clark C, Daniel GE, Dixon PB, Hook EW 3rd; CT/NG Study Group. Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2013 Jun;51(6):1666-72. doi: 10.1128/JCM.03461-12. Epub 2013 Mar 6.

  PMID: 23467600 BACKGROUND

• Holley CE, Van Pham T, Mezzadra HM, Willis GC, Witting MD. Overtreatment of gonorrhea and chlamydial infections in 2 inner-city emergency departments. Am J Emerg Med. 2015 Sep;33(9):1265-8. doi: 10.1016/j.ajem.2015.06.009. Epub 2015 Jun 12.

  PMID: 26119905 BACKGROUND

• Newman LM, Moran JS, Workowski KA. Update on the management of gonorrhea in adults in the United States. Clin Infect Dis. 2007 Apr 1;44 Suppl 3:S84-101. doi: 10.1086/511422.

  PMID: 17342672 BACKGROUND

• Tabrizi SN, Unemo M, Golparian D, Twin J, Limnios AE, Lahra M, Guy R; TTANGO Investigators. Analytical evaluation of GeneXpert CT/NG, the first genetic point-of-care assay for simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis. J Clin Microbiol. 2013 Jun;51(6):1945-7. doi: 10.1128/JCM.00806-13. Epub 2013 Apr 3.

  PMID: 23554203 BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia Infections

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Limitations and Caveats

Early termination leading to small numbers of subjects enrolled

Results Point of Contact

• Title: Richard Gentry Wilkerson
• Organization: University of Maryland School of Medicine

gwilkerson@som.umaryland.edu

4103285555

Study Officials

• Richard G Wilkerson, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, investigators, and care providers will be masked to the experimental or control arm prior to enrollment in the study. Once the participant has been enrolled in the study, they will be randomized to either the control arm or the experimental arm. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective, non-blinded, randomized clinical control trial

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: September 24, 2018
• Primary Completion: March 25, 2022
• Study Completion: June 20, 2023
• Last Updated: August 31, 2023
• Results First Posted: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)