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Rapid Diagnostic Assay for Gonorrhea and Chlamydia
NA trial testing Rapid 30-minute Desktop Assay in Urethritis in 98 participants. Completed in 30 June 2024.
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 98 |
| Start date | 22 March 2023 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across United States |
Massachusetts General Hospital
18 and older, any sex, with Urethritis or Cervicitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test.
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care | 7 | 0 – 8 |
| Rapid STI Test | 1 | 0 – 7 |
The investigators will compare visit duration between participants randomized to the point-of-care test and those to the 30-minute desktop test. Participant visit duration will be calculated as the difference between when the participant enters the exam room and when they check out of the clinic, in minutes.
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care | 57 | 45 – 69 |
| Rapid STI Test | 87 | 72 – 97 |
The investigators will compare time from specimen collection to availability of test result between the point-of-care gram stain or rapid 30-minute desktop test. Providers will record time of specimen collection and time of result (for point of care gram stain), time of result for the rapid desktop platform will be extracted from the platform; time to result will be calculated as the difference between those times, in minutes.
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care | 6.5 | 5 – 9 |
| Rapid STI Test | 34 | 33 – 36 |
Proportion of participants in each arm who recevied gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was positive for gonorrhea, or who did not receive gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was negative for gonorrhea
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care | 41 | |
| Rapid STI Test | 46 |
Proportion of participants in each arm who were prescribed an antibiotic with activity against gonorrhea on the day of clinic visit, either for a positive test result or for a clinical syndrome for which the antibiotics are indicated (e.g., a clinical diagnosis of pelvic inflammatory disease, a diagnosis of non-gonococcal urethritis) as determined by study PI; or who were not prescribed an antibiotic with activity against gonorrhea on the day of clinic visit in the absence of a positive test result for gonorrhea or clinical syndrome for which the antibiotics are indicated.
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care | 43 | |
| Rapid STI Test | 48 |
The proportion of point of care gram stain results (control arm) or rapid test results (intervention arm) that were unavailable or invalid (unable to be read or provided an error message) at the time of the clinic visit.
| Group | Value | 95% CI |
|---|---|---|
| Standard of Care | 4 | |
| Rapid STI Test | 0 |
This study is a pilot randomized controlled trial evaluating the use of either a) rapid 30-minute desktop assay or b) point-of-care gram stain (current standard of care) to guide the clinical management of patients with symptomatic urethritis or cervicitis evaluated in the Massachusetts General Hospital Sexual Health Clinic. Patients presenting with symptoms of urethritis or cervicitis and meeting inclusion criteria will be randomized to have diagnostic specimens tested during the clinical encounter using either the 30-minute desktop assay or point-of-care gram stain. Patients randomized to the intervention arm of the study will also have a gram stain created, which will be held for interpretation by the clinician following the clinical encounter. Patients will not be followed longitudinally. Recruitment will conclude when 100 participants enroll in the study.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing