Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06090565 |
Other study ID # |
9937 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
April 1, 2021 |
Est. completion date |
December 22, 2022 |
Study information
Verified date |
October 2023 |
Source |
Bulovka Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
A non-inferiority, open-label, multicentre randomised controlled trial to compare two
therapeutic regimens for the treatment of uncomplicated urogenital, rectal or pharyngeal
gonorrhoea in men and women between 18 and 75 years of age. Patients were enrolled and
treated from April 2021 to June 2022 at the Dermatovenerology Department, University Hospital
Bulovka, Prague, Czech Republic and the Venereology Prague, Medicentrum Beroun, Prague, Czech
Republic.
Description:
Non-inferiority, open-label, multicentre randomised clinical trial (RCT) compared two
regimens for the treatment of uncomplicated urogenital, rectal or pharyngeal gonorrhoea in
men and women between 18 and 65 years of age. Patients were enrolled and treated from April
2021 to June 2022 at the Dermatovenerology Department, University Hospital Bulovka, Prague,
and the Venereology Prague, Medicentrum Beroun, Prague, Czech Republic.
Laboratory testing The diagnosis of gonorrhoea and C. trachomatis infection was established
from urogenital, rectal and pharyngeal swab specimens. Laboratory testing for inclusion in
the study and at 3 weeks after initiation of treatment was performed using the Cobas 4800
CT/NG NAAT assay (Roche Diagnostics, Indianapolis, IN, USA). At test of cure visits 1 and 3
weeks after the initiation of treatment, swabs for cultivation of N. gonorrhoeae were also
sampled and immediately inoculated onto non-selective and selective Modified Thayer-Martin
agar plates. Inoculated agar plates were directly transferred to the hospital laboratory for
incubation at 36°C in a humid 5% CO2-enriched atmosphere for 48 hours. Suspected gonococcal
colonies were species verified using the biochemical NEISSERIAtest® (LACHEMA, Brno, Czech
Republic) or the PolyViteX VCAT3® medium (Biomérieux, Marcy l'Etoile, France).
Statistical analyses Sample size was based on assessing non-inferiority of the cefixime plus
doxycycline arm compared to the ceftriaxone plus azithromycin arm with a one-sided 5% type I
error rate. We estimated the sample size based on estimates from other gonorrhoea treatment
studies and expert opinions. The target sample size of 152 participants (76 per group) was
based on an assumed treatment failure of 0% in the ceftriaxone-azithromycin arm and 2% in the
cefixime-doxycycline arm, which would provide at least 90% power for the comparison of the
primary endpoint. Intention-to-treat (ITT) and per-protocol analyses were done; per protocol
results are reported here and ITT results in the online supplement. The ITT population was
composed of all randomised patients; the per-protocol population consisted of patients who
were randomised, received the allocated regimen (for doxycycline, at least ≥85% (12/14) of
the prescribed dose) underwent follow-up examinations, and abstained from any sexual
activities, including protected intercourse, during the study period. For each study group,
the proportion of patients with urogenital, rectal or pharyngeal gonorrhoea who achieved
microbiological cure was calculated. The Clopper-Pearson exact method was used to estimate
confidence intervals (CIs). We used chi-square tests (Pearson's or Fisher's test when less
than five observations) for binomial outcome measures and Student's t test for continuous
outcome measures, as appropriate.