Gonorrhea Clinical Trial
Official title:
Gonorrhoea Resistance Assessment by Nucleic Acid Detection: A Program Evaluation
Three sexual health clinical services across Australia and their associated pathology testing laboratories are implementing a new management program for gonorrhoea infection. The services are implementing the use of gonorrhoea drug resistance testing as part of routine clinical and laboratory practice, where drug resistance test results are provided to clinicians quickly to guide choice of antibiotic therapy. Clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone.
This study aims to demonstrate the feasibility of a new approach to antibiotic stewardship based on individually tailored antibiotic prescribing. Three sexual health clinical services in New South Wales Australia with high caseloads of gay and bisexual men will adopt a new management practice for gonorrhoea infection involving provision of tailored antibiotic therapy by clinicians at the time of gonorrhoea diagnosis and treatment, guided by the results of resistance testing. The services are implementing the use of gonorrhoea drug resistance testing as part of routine clinical and laboratory practice, where drug resistance test results are provided to clinicians quickly to guide choice of antibiotic therapy. This differs from existing practice where the prolonged turn-around times for drug resistance testing results mean clinicians must prescribe drug therapy without knowing these results. This can lead to increasing levels of drug resistance to ceftriaxone. The drug resistance test used in the new program detects genetic material (nucleic acids). It was developed and validated in Australia and is as accurate as existing culture-based drug resistance testing but provides quicker results. Patients treated presumptively at their first clinic visit will be treated with standard of care ceftriaxone. However, for cases treated at the return visit, clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone. This will preserve ceftriaxone for situations where it must be used as the only effective drug available. Established patient follow-up procedures at clinical services will confirm that treatment has been successful. Quantitative data from the clinical and laboratory services in the study will be used to assess the proportion of all cases treated with ceftriaxone. The cure rate in gonorrhoea cases within the new management program versus standard care will also be assessed which will help illustrate the impact of the new management program. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01439503 -
Safer Sex Program for Young African-American Men
|
Phase 2 | |
| Completed |
NCT00381992 -
Risk Assessment of Long-Haul Truck Drivers
|
N/A | |
| Completed |
NCT03294395 -
New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea
|
Phase 3 | |
| Not yet recruiting |
NCT06428643 -
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
|
N/A | |
| Completed |
NCT03896776 -
A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
|
N/A | |
| Completed |
NCT03718806 -
Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin
|
Phase 1 | |
| Completed |
NCT04010539 -
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
|
Phase 3 | |
| Completed |
NCT00262106 -
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
|
Phase 3 | |
| Completed |
NCT00187902 -
Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM
|
N/A | |
| Completed |
NCT00207506 -
Lay Health Advisors for Sexually Transmitted Disease Prevention
|
Phase 1/Phase 2 | |
| Completed |
NCT04553068 -
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
|
Phase 3 | |
| Active, not recruiting |
NCT03959527 -
Zoliflodacin in Uncomplicated Gonorrhoea
|
Phase 3 | |
| Active, not recruiting |
NCT03980223 -
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
|
Phase 4 | |
| Completed |
NCT01465607 -
Implementation of an Efficacious Intervention for High Risk Women in Mexico
|
N/A | |
| Terminated |
NCT00120770 -
Cellulose Sulfate (CS) Gel and HIV in Nigeria
|
Phase 3 | |
| Completed |
NCT02391233 -
Multimedia WORTH With Black Drug-Involved Women on Probation
|
N/A | |
| Recruiting |
NCT05766904 -
Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections
|
Phase 3 | |
| Completed |
NCT04297436 -
Gonococcal Vaccine Study in Key Populations in Kenya
|
N/A | |
| Completed |
NCT03098329 -
Check it: A New Approach to Controlling Chlamydia Transmission in Young People
|
N/A | |
| Completed |
NCT02122094 -
Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
|
N/A |