Neisseria Gonorrhoeae InfectionPhase 2NCT05216744
Comparison of Efficacy of Two Combination Regimens for the Neisseria Gonorrhoeae and Chlamydia Coinfection
A Phase 2 study testing Ceftriaxone 1000mg + doxycycline 100 mg and Cefixime 800mg + doxycycline 100 mg in people with Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
- What is being tested?
- Ceftriaxone 1000mg + doxycycline 100 mg and Cefixime 800mg + doxycycline 100 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jul 2021to 20 Feb 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 ages with laboratory-documented uncomplicated Chlamydia trachomatis and Neisseria gonorrhoeae reinfection at any site
Who cannot join
- Pregnancy
- Breast feeding
- Hypersensitivity to cephalosporins or penicillins
- significant renal failure or hepatic failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Two Combination Regimens for the Treatment of Uncomplicated Neisseria Gonorrhoeae and Chlamydia Trachomatis Coinfection
The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.
Read the detailed description
Gonococcal infections, including urethritis, cervicitis, epididymitis, and proctitis, are a significant cause of morbidity among sexually active men and women. The treatment of these sexually transmitted infections (STIs) has evolved over the years, mainly due to the emergence of antibiotic resistance. The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates. Ceftriaxone is highly effective against susceptible N. gonorrhoeae. Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. These doses of ceftriaxone are higher than previously recommended due to concerns regarding rising gonococcal minimum inhibitory concentrations (MICs) worldwide. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline (100 mg orally twice daily for seven days) was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.
- Being tested
- Ceftriaxone 1000mg + doxycycline 100 mg, Cefixime 800mg + doxycycline 100 mg
- Keywords
- Neisseria Gonorrhoeae, Chlamydia Trachomatis, reinfection
- Medical subject headings
- Gonorrhea, Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone 1000mg + doxycycline 100 mgDrug
Also called Ceftriaxone 1000mg IV plus doxycycline 100 mg PO twice daily in 7 days
Study comparing the effectiveness of two combination regimens in the treatment of gonorrhea and chlamydia, including regimen A (100mg doxycycline orally twice a day for 7 days + 1 dose of 1000mg ceftriaxone intravenously) and regimen B (100mg doxycycline). orally for 7 days + 1 oral dose of 800mg cefixime)
Cefixime 800mg + doxycycline 100 mgDrug
Also called a single oral dose of Cefixime 800mg plus doxycycline 100 mg PO twice daily in 7 days
Study comparing the effectiveness of two combination regimens in the treatment of gonorrhea and chlamydia, including regimen A (100mg doxycycline orally twice a day for 7 days + 1 dose of 1000mg ceftriaxone intravenously) and regimen B (100mg doxycycline). orally for 7 days + 1 oral dose of 800mg cefixime)
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline plus ceftriaxone | Experimental | Each subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously Receives: Drug: Ceftriaxone 1000mg + doxycycline 100 mg |
| Doxycycline plus cefixime | Active comparator | Each subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg Receives: Drug: Cefixime 800mg + doxycycline 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae
Measured: 5th day after treatment
Secondary outcomes (1)
Side effects
Any side effects from interventions in two arms
Measured: From 1st day of study to 5th day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start15 Jul 2021
- Primary completion15 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neisseria Gonorrhoeae InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject will receive one of two combination regimens including regimen A (Doxycycline plus Cefixime) or regimen B (Doxycycline plus Ceftriaxone).
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haiphong University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuong Nguyen, PhD, Study director, Hai Phong University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216744
- Sponsor's protocol ID
- HPMU.19.10.21
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen PTT, Pham HV, Van DH, Pham LV, Nguyen HT, Nguyen HV. Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection. BMC Infect Dis. 2022 Jul 9;22(1):607. doi: 10.1186/s12879-022-07595-w.
PubMed 35810277
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Two Combination Regimens for the Treatment of Uncomplicated Neisseria Gonorrhoeae and Chlamydia Trachomatis Coinfection
- ClinicalTrials.gov ID
- NCT05216744
- Acronym / sponsor ID
- HPMU.19.10.21
- Keywords
- Neisseria Gonorrhoeae, Chlamydia Trachomatis, reinfection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Haiphong University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 31 Jan 2022 (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.
The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates.Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.
Detailed description
Gonococcal infections, including urethritis, cervicitis, epididymitis, and proctitis, are a significant cause of morbidity among sexually active men and women. The treatment of these sexually transmitted infections (STIs) has evolved over the years, mainly due to the emergence of antibiotic resistance. The frequency of Chlamydia trachomatis and Neisseria gonorrhoeae coinfection can vary depending on their individual incidence and prevalence rates. Ceftriaxone is highly effective against susceptible N. gonorrhoeae. Single-agent therapy with ceftriaxone is the preferred regimen for treatment of gonococcal infections. These doses of ceftriaxone are higher than previously recommended due to concerns regarding rising gonococcal minimum inhibitory concentrations (MICs) worldwide. If an injectable cephalosporin is not available, cefixime is the only oral cephalosporin that can be used for gonococcal therapy. Doxycycline (100 mg orally twice daily for seven days) was recommended for presumptive treatment of chlamydia in nonpregnant individuals with gonococcal infection. The study is conducted to evaluate the effectiveness of two regimens in combination with doxycycline with cefixime or ceftriaxone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject will receive one of two combination regimens including regimen A (Doxycycline plus Cefixime) or regimen B (Doxycycline plus Ceftriaxone).
| Arm | Type | Receives |
|---|---|---|
| Doxycycline plus ceftriaxone | Experimental | Drug: Ceftriaxone 1000mg + doxycycline 100 mgEach subject will receive 100 mg doxycycline twice daily for seven days and a single dose of ceftriaxone 1000 mg intravenously |
| Doxycycline plus cefixime | Active comparator | Drug: Cefixime 800mg + doxycycline 100 mgEach subject will receive 100 mg doxycycline twice daily for seven days and a single oral dose of cefixime 800 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient over 18 ages with laboratory-documented uncomplicated Chlamydia trachomatis and Neisseria gonorrhoeae reinfection at any site
Key exclusion criteria (4 listed)
- Pregnancy
- Breast feeding
- Hypersensitivity to cephalosporins or penicillins
- significant renal failure or hepatic failure
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 |
|---|---|---|
| Ceftriaxone 1000mg + doxycycline 100 mgAlso: Ceftriaxone 1000mg IV plus doxycycline 100 mg PO twice daily in 7 daysStudy comparing the effectiveness of two combination regimens in the treatment of gonorrhea and chlamydia, including regimen A (100mg doxycycline orally twice a day for 7 days + 1 dose of 1000mg ceftriaxone intravenously) and regimen B (100mg doxycycline). orally for 7 days + 1 oral dose of 800mg cefixime) | Drug | Doxycycline plus ceftriaxone |
| Cefixime 800mg + doxycycline 100 mgAlso: a single oral dose of Cefixime 800mg plus doxycycline 100 mg PO twice daily in 7 daysStudy comparing the effectiveness of two combination regimens in the treatment of gonorrhea and chlamydia, including regimen A (100mg doxycycline orally twice a day for 7 days + 1 dose of 1000mg ceftriaxone intravenously) and regimen B (100mg doxycycline). orally for 7 days + 1 oral dose of 800mg cefixime) | Drug | Doxycycline plus cefixime |
Primary outcome
cure rate
Time frame: 5th day after treatment
a negative test of cure for Chlamydia trachomatis and Neisseria gonorrhoeae
1 secondary outcome
Side effects
Time frame: From 1st day of study to 5th day after treatment
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 17 Mar 2022.
- Derived from this study: PubMed 35810277Nguyen PTT, Pham HV, Van DH, Pham LV, Nguyen HT, Nguyen HV. Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection. BMC Infect Dis. 2022 Jul 9;22(1):607. doi: 10.1186/s12879-022-07595-w.
- 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.
Phuong Nguyen, PhD study director
Hai Phong University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceftriaxone 1000mg + doxycycline 100 mg and Cefixime 800mg + doxycycline 100 mg in people with Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
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 4 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
cure rate (time frame: 5th day after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05216744, which also lists 1 linked publication.
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 17 Mar 2022.