GonorrheaPhase 4NCT06090565
Cefixime Plus Doxycycline Compared to Ceftriaxone Plus Azithromycin for Treatment of Gonorrhoea
A Phase 4 study testing Cefixime, Doxycyclin and Ceftriaxon in people with Gonorrhea, run by Bulovka Hospital at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gonorrhea
- What is being tested?
- Cefixime, Doxycyclin and Ceftriaxon
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Apr 2021to 22 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uncomplicated urogenital, rectal or pharyngeal gonorrhoea diagnosed using the nucleic acid amplification test
Who cannot join
- any antimicrobial treatment during the 4 weeks before study enrolment
- pregnancy or lactation
- autoimmune disease
- renal, hepatic or cardiac insufficiency
- immunosuppressive therapy
- allergy to cephalosporins, macrolides or doxycycline
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Venereology Prague, Medicentrum Beroun
Prague, 15000
University Hospital Bulovka
Prague, 18081
About this study
Official title: Cefixime 800 mg Plus Doxycycline 100 mg b.i.d. for 7 Days Compared to Ceftriaxone 1 g Plus Azithromycin 2 g for Treatment of Urogenital, Rectal and Pharyngeal Gonorrhoea: A Randomised Controlled Trial
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.
Read the detailed 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.
- Conditions
- Gonorrhea
- Being tested
- Cefixime, Doxycyclin, Ceftriaxon, Azithromycin
- Keywords
- Neisseria gonorrhoeae, Cefixime, Azithromycin, Ceftriaxone, Doxycycline
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefiximeDrug
Also called Cefixime (ATC code J01DD08)
Two 400 mg tablets will be administered orally to equal a 800 mg dose.
DoxycyclinDrug
Also called Doxyhexal (ATC code J01AA02)
One 100 mg tablet will be administered orally twice a day for 7 days
CeftriaxonDrug
Also called Ceftriaxone (ATC code J01DD04)
Dose of 1 g intramuscular one time
AzithromycinDrug
Also called Sumamed (ATC code J01FA10)
Four 500 mg tablets will be administered orally to equal a 2 g dose.
| Study group | Role | What they receive |
|---|---|---|
| Cefixime plus doxycycline | Experimental | Single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days Receives: Drug: Cefixime; Drug: Doxycyclin |
| Ceftriaxone plus azithromycin | Active comparator | Single dose ceftriaxone 1 g plus single-dose azithromycin 2 g Receives: Drug: Ceftriaxon; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with negative cultures 1 and 3 weeks and a negative NAAT 3 weeks (±3 days) after treatment initiation.
To assess the eradication rate of Neisseria gonorrhoeae by culture and NAAT following a single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g (Intent to Treat population).
Measured: One and three weeks (±3 days)
Secondary outcomes (2)
Number of Participants with clinical cure defined as disappearance of clinical symptoms and signs 1 week after treatment according to the clinical assessment of the patient by the physician.
To assess clinical cure (disapperance of clinical symptoms and sings) following a single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g (Intent to Treat population).
Measured: One week (±3 days)
Occurrence of treatment-related severe adverse events in treatment groups
Adverse event frequency and severity will be compared between patients who received single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g
Measured: One and three weeks (±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Apr 2021
- Primary completion30 Jun 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomised to cefixime 800 mg single oral dose plus doxycycline 100 mg twice a day orally for 7 days or the comparator ceftriaxone 1 g single intramuscular dose plus azithromycin 2 g single oral dose with a computer-generated pseudo-random code using permuted block randomisation in a 1:1 ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulovka Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Principal investigator, Filip Rob MD, PhD, Bulovka Hospital
- Investigators
- Filip Rob, MD, PhD, Principal investigator, Nemocnice Na Bulovce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090565
- Sponsor's protocol ID
- 9937
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefixime 800 mg Plus Doxycycline 100 mg b.i.d. for 7 Days Compared to Ceftriaxone 1 g Plus Azithromycin 2 g for Treatment of Urogenital, Rectal and Pharyngeal Gonorrhoea: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06090565
- Acronym / sponsor ID
- 9937
- Conditions
- Gonorrhea
- Keywords
- Neisseria gonorrhoeae, Cefixime, Azithromycin, Ceftriaxone, Doxycycline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Bulovka HospitalUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomised to cefixime 800 mg single oral dose plus doxycycline 100 mg twice a day orally for 7 days or the comparator ceftriaxone 1 g single intramuscular dose plus azithromycin 2 g single oral dose with a computer-generated pseudo-random code using permuted block randomisation in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Cefixime plus doxycycline | Experimental | Drug: Cefixime, Drug: DoxycyclinSingle-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days |
| Ceftriaxone plus azithromycin | Active comparator | Drug: Ceftriaxon, Drug: AzithromycinSingle dose ceftriaxone 1 g plus single-dose azithromycin 2 g |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- uncomplicated urogenital, rectal or pharyngeal gonorrhoea diagnosed using the nucleic acid amplification test
Key exclusion criteria (6 listed)
- any antimicrobial treatment during the 4 weeks before study enrolment
- pregnancy or lactation
- autoimmune disease
- renal, hepatic or cardiac insufficiency
- immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefiximeAlso: Cefixime (ATC code J01DD08)Two 400 mg tablets will be administered orally to equal a 800 mg dose. | Drug | Cefixime plus doxycycline |
| DoxycyclinAlso: Doxyhexal (ATC code J01AA02)One 100 mg tablet will be administered orally twice a day for 7 days | Drug | Cefixime plus doxycycline |
| CeftriaxonAlso: Ceftriaxone (ATC code J01DD04)Dose of 1 g intramuscular one time | Drug | Ceftriaxone plus azithromycin |
| AzithromycinAlso: Sumamed (ATC code J01FA10)Four 500 mg tablets will be administered orally to equal a 2 g dose. | Drug | Ceftriaxone plus azithromycin |
Primary outcome
Number of Participants with negative cultures 1 and 3 weeks and a negative NAAT 3 weeks (±3 days) after treatment initiation.
Time frame: One and three weeks (±3 days)
To assess the eradication rate of Neisseria gonorrhoeae by culture and NAAT following a single-dose cefixime 800 mg plus doxycycline 100 mg b.i.d. for 7 days compared to single-dose ceftriaxone 1 g plus single-dose azithromycin 2 g (Intent to Treat population).
2 secondary outcomes
Number of Participants with clinical cure defined as disappearance of clinical symptoms and signs 1 week after treatment according to the clinical assessment of the patient by the physician.
Time frame: One week (±3 days)
Occurrence of treatment-related severe adverse events in treatment groups
Time frame: One and three weeks (±3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Rob, MD, PhD principal investigator
Nemocnice Na Bulovce
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefixime, Doxycyclin and Ceftriaxon in people with Gonorrhea, run by Bulovka Hospital at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with negative cultures 1 and 3 weeks and a negative NAAT 3 weeks (±3 days) after treatment initiation. (time frame: One and three weeks (±3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.