Uncomplicated Urogenital GonorrheaPhase 3SOLITAIRE-UNCT02210325
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
A Phase 3 study testing solithromycin, ceftriaxone and azithromycin in people with Uncomplicated Urogenital Gonorrhea, run by Melinta Therapeutics, Inc. at 5 sites in 2 countries.
Trial summary
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Uncomplicated Urogenital Gonorrhea
- What is being tested?
- solithromycin, ceftriaxone and azithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2014to 22 Feb 2017
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 1 of the following:
- Untreated male with urethral gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
- Untreated female with cervical gonorrhea as determined by a screening laboratory test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study drug administration.
- Urethral (male) or cervical (female) Gram stain demonstrating Gram-negative intracellular diplococci and leukocytes.
- The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all of these until study completion.
- Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.
Who cannot join
- Confirmed or suspected complicated or systemic gonococcal infections such as pelvic inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated gonococcal infection.
- Individuals who have already received antibiotic treatment for their gonorrhea.
- Use of systemic or intravaginal antibiotics within 7 days prior to study drug administration.
- Women who are pregnant or nursing.
- Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.
- History of significant intolerance or allergy to macrolide or cephalosporin antibiotics.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Study site
Baltimore, Maryland, 21205
Study site
Cleveland, Ohio, 44109
Study site
Toledo, Ohio, 43614
Australia2 sites
Study site
Melbourne, Victoria, 3053
Study site
Sydney, New South Wales, 2000
About this study
Official title: An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.
- Conditions
- Uncomplicated Urogenital Gonorrhea
- Being tested
- solithromycin, ceftriaxone, azithromycin
- Keywords
- gonorrhea, chlamydia, solithromycin
- Medical subject headings
- Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solithromycinDrug
ceftriaxoneDrug
azithromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone plus Azithromycin | Active comparator | A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin Receives: Drug: ceftriaxone; Drug: azithromycin |
| Solithromycin | Experimental | A single oral dose of 1000 mg solithromycin Receives: Drug: solithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.
Measured: 7 days after treatment
Secondary outcomes (3)
To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea
Adverse event frequency and severity will be compared between patients who received solithromycin and those who received ceftriaxone plus azithromycin
Measured: 7 days
To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin.
Measured: 7 days
To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.
Measured: 21 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion22 Feb 2017
- Study completion22 Feb 2017
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 Uncomplicated Urogenital 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Chen, MD, PhD, Principal investigator, Melbourne Sexual Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210325
- Sponsor's protocol ID
- CE01-302
- Other IDs
- 15-0091, HHSN272201300013
- Acronym
- SOLITAIRE-U
- Status last verified
- Sep 2017
- First submitted
- 1 Aug 2014
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chen MY, McNulty A, Avery A, Whiley D, Tabrizi SN, Hardy D, Das AF, Nenninger A, Fairley CK, Hocking JS, Bradshaw CS, Donovan B, Howden BP, Oldach D; Solitaire-U Team. Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial. Lancet Infect Dis. 2019 Aug;19(8):833-842. doi: 10.1016/S1473-3099(19)30116-1. Epub 2019 Jun 10.
PubMed 31196813
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia
- ClinicalTrials.gov ID
- NCT02210325
- Acronym / sponsor ID
- SOLITAIRE-U / CE01-302
- Conditions
- Uncomplicated Urogenital Gonorrhea
- Keywords
- gonorrhea, chlamydia, solithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Aug 2014 (actual)
- Primary completion
- 22 Feb 2017 (actual)
- Study completion
- 22 Feb 2017 (actual)
- First posted
- 6 Aug 2014 (estimated)
- 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.
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone plus Azithromycin | Active comparator | Drug: ceftriaxone, Drug: azithromycinA single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin |
| Solithromycin | Experimental | Drug: solithromycinA single oral dose of 1000 mg solithromycin |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- At least 1 of the following:
- The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all of these until study completion.
- Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.
Key exclusion criteria (6 listed)
- Confirmed or suspected complicated or systemic gonococcal infections such as pelvic inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated gonococcal infection.
- Individuals who have already received antibiotic treatment for their gonorrhea.
- Use of systemic or intravaginal antibiotics within 7 days prior to study drug administration.
- Women who are pregnant or nursing.
- Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.
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 |
|---|---|---|
| solithromycin | Drug | Solithromycin |
| ceftriaxone | Drug | Ceftriaxone plus Azithromycin |
| azithromycin | Drug | Ceftriaxone plus Azithromycin |
Primary outcome
To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.
Time frame: 7 days after treatment
3 secondary outcomes
To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea
Time frame: 7 days
To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin.
Time frame: 7 days
To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.
Time frame: 21 days 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 11 Sep 2017.
- Derived from this study: PubMed 31196813Chen MY, McNulty A, Avery A, Whiley D, Tabrizi SN, Hardy D, Das AF, Nenninger A, Fairley CK, Hocking JS, Bradshaw CS, Donovan B, Howden BP, Oldach D; Solitaire-U Team. Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial. Lancet Infect Dis. 2019 Aug;19(8):833-842. doi: 10.1016/S1473-3099(19)30116-1. Epub 2019 Jun 10.
- Individual participant dataSharing planned: No
Related trials for Uncomplicated Urogenital Gonorrhea
RecruitingPhase 3
500-mg Versus 1000-mg Ceftriaxone for Uncomplicated Gonorrhea Infection
Gonorrhea Infection
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.
Marcus Chen, MD, PhD principal investigator
Melbourne Sexual Health Centre
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing solithromycin, ceftriaxone and azithromycin in people with Uncomplicated Urogenital Gonorrhea, run by Melinta Therapeutics, Inc. at 5 sites in 2 countries.
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 6 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population. (time frame: 7 days 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 NCT02210325, 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 11 Sep 2017.