GonorrheaPhase 3NCT03959527
Zoliflodacin in Uncomplicated Gonorrhoea
A Phase 3 study testing zoliflodacin, ceftriaxone and azithromycin in people with Gonorrhea, run by Global Antibiotics Research and Development Partnership at 17 sites in 5 countries.
Trial summary
This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Gonorrhea
- What is being tested?
- zoliflodacin, ceftriaxone and azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 6 Nov 2019to 18 Sep 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance)
- Weight ≥ 35 kg
- Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture)
- For females of child-bearing potential, a negative urine pregnancy test at screening
- For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study.
- For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment
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- Willingness to comply with trial protocol
- Willingness to undergo HIV testing
- Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit
- Willingness and ability to give written informed consent or be consented by a legal representative or provide assent and parental consent (for minors, as appropriate).
Who cannot join
- Confirmed or suspected complicated or disseminated gonorrhoea
- Pregnant or breastfeeding women
- Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
- Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
- Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening
- Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is greater, prior to screening
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- Cytotoxic or radiation therapy within 30 days prior to screening
- Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug based on medical history and physical examination
- History of urogenital sex-reassignment surgery
- Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count <200 cells/μL
- Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation
- Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics
- Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments)
- Receipt or planned receipt of an investigational product in a clinical trial within 30 days or five half-lives of the drug, whichever is greater, prior to screening until end of participation to this clinical trial
- History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator
- Severe medical or psychiatric condition which, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of trial results or affect the individual's ability to provide informed consent
- Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol
- Previous randomisation in this clinical trial.
- Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States6 sites
Jefferson County Department of Health
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006
Bell Flower Clinic
Indianapolis, Indiana, 46202
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
San Francisco Department Of Public Health City Clinic
San Francisco, California, 94103
Public Health - Seattle & King County STD Clinic
Seattle, Washington, 98104
South Africa6 sites
SAMRC Botha's Hill Clinical Research Site
Bothas Hill, 3660
Masiphumelele Research Site
Cape Town, 7975
Ndlovu Research Centre
Elandsdoorn, 0470
Wits RHI
Johannesburg, 2001
Setshaba Research Centre
Soshanguve, 0152
SAMRC Tongaat Clinical Research Site
Tongaat, 4400
Thailand3 sites
Bangrak STI Center
Bangkok, 10120
Institute of HIV Research and Innovation
Bangkok, 10330
Silom Community Clinic
Bangkok, 10400
Netherlands1 site
Public Health Service (GGD) Amsterdam / STI Outpatient Clinic
Amsterdam, 1018 WT
About this study
Official title: A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea
This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.
- Conditions
- Gonorrhea
- Being tested
- zoliflodacin, ceftriaxone, azithromycin
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoliflodacinDrug
Dose: 3g, oral administration
ceftriaxoneDrug
Dose: 500mg, Intra-Muscular (IM) administration
azithromycinDrug
Dose: 1g, oral administration
| Study group | Role | What they receive |
|---|---|---|
| zoliflodacin | Experimental | Participant in this arm will receive a single dose of zoliflodacin. Receives: Drug: zoliflodacin |
| ceftriaxone and azithromycin combination | Active comparator | Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). Receives: Drug: ceftriaxone; Drug: azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.
Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at test of cure visit in micro-ITT (urogenital) analysis set
Measured: Day 6 (+/- 2)
Secondary outcomes (34)
Safety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.
Incidence, severity, causality and seriousness of treatment-emergent adverse events (including clinically significant abnormal laboratory values/procedures i.e., physical examination per protocol)
Measured: Day 30
Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Proportion of participants with microbiological cure as determined by NG culture at pharyngeal sites at test of cure visit in micro-ITT (Pharyngeal).
Measured: Day 6
Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Proportion of participants with microbiological cure as determined by NG culture at rectal sites at test of cure visit in micro-ITT (Rectal).
Measured: Day 6
The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Proportion of male at birth participants experiencing resolution of signs and symptoms of urogenital gonococcal infection that were present at enrolment, at test of cure visit in Clinical Cure Population.
Measured: Day 6
Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin
Proportion of female participants with microbiological cure, as determined by NG culture at cervical site of infection, at TOC in micro-ITT (Urogenital) population
Measured: Day 6
Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin
Proportion of male participants with microbiological cure as determined by NG culture at urethral site of infection at TOC visit, in micro-ITT population
Measured: Day 6
Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Proportion of participants with a positive NG NAAT result from urethral or cervical sites at baseline and a negative NG NAAT result at test of cure visit in micro-ITT analysis set.
Measured: Day 6
Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Proportion of participants with a positive NG NAAT at baseline from pharyngeal sites and a negative NG NAAT at test of cure visit in micro-ITT analysis set.
Measured: Day 6
Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Proportion of participants with a positive NG NAAT from rectal sites at baseline and a negative NG NAAT at test of cure visit in micro-ITT analysis set.
Measured: Day 6
Arithmetic Mean Plasma Concentration of Zoliflodacin
Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following oral administration of single oral dose of zoliflodacin 3 g
Measured: 15 min - 1 hour
Arithmetic Mean Plasma Concentration of Zoliflodacin
Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following a single oral dose administration of zoliflodacin 3 g
Measured: 2-2.5 h
Arithmetic Mean Plasma Concentration of Zoliflodacin
Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g
Measured: 4.5 - 5h
Arithmetic Mean Plasma Concentration of Zoliflodacin
Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose zoliflodacin 3 g
Measured: 10 -12 h
Arithmetic Mean Plasma Concentration of Zoliflodacin
Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g
Measured: 24 - 36 h
Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin
Geometric mean time to last (Tlast) plasma concentration above the lower limit of quantitation
Measured: Day 2
Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin
Geometric mean time to maximum plasma concentration (Tmax) after a single, oral, 3 g dose of zoliflodacin
Measured: Day 2
Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin
Geometric mean maximum plasma concentration (Cmax) after a single, oral 3 g dose of zoliflodacin
Measured: Day 2
Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin
Geometric mean plasma area under the concentration-time curve (AUC0-last) from time zero to the last concentration above lower level of quantification
Measured: Day 2
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)
Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (Day 1)
Measured: Day 1
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.
Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline
Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline
Measured: Day 1
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.
Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline
Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline
Measured: Day 1
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.
Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline
Antimicrobial susceptibility to ciprofloxacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (zoliflodacin arm only since no microbiological failures in comparator arm)
Measured: Day 1
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit
Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline
Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline
Measured: Day 1
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.
Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline
Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline
Measured: Day 1
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit
Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline
Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline
Measured: Day 1
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit
Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline
Antimicrobial susceptibility to zolflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline
Measured: Day 1
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit
Antimicrobial susceptibility to zoliflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start6 Nov 2019
- Primary completion30 Aug 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single dose of Zoliflodacin or comparators combination in single dose: ceftriaxone and azithromycin
- Masking
- None (open label)
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Antibiotics Research and Development Partnership
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959527
- Sponsor's protocol ID
- STI_Zoli001
- Other IDs
- 2019-000990-22, 2019
- Status last verified
- Sep 2025
- First submitted
- 2 May 2019
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Luckey A, Balasegaram M, Barbee LA, Batteiger TA, Broadhurst H, Cohen SE, Delany-Moretlwe S, de Vries HJC, Dionne JA, Gill K, Kenyon C, Kittiyaowamarn R, Lewis D, Mueller JP, Naicker V, O'Brien S, O'Donnell JP, Phanuphak N, Spooner E, Srinivasan S, Taylor SN, Unemo M, Zwane Z, Hook EW 3rd; Zoliflodacin Phase 3 Study Group. Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial. Lancet. 2026 Jan 10;407(10524):147-160. doi: 10.1016/S0140-6736(25)01953-1. Epub 2025 Dec 11.
PubMed 41391465Jacobsson S, Golparian D, Oxelbark J, Kong FYS, Da Costa RMA, Franceschi F, Brown D, Louie A, Drusano G, Unemo M. Pharmacodynamics of zoliflodacin plus doxycycline combination therapy against Neisseria gonorrhoeae in a gonococcal hollow-fiber infection model. Front Pharmacol. 2023 Dec 7;14:1291885. doi: 10.3389/fphar.2023.1291885. eCollection 2023.
PubMed 38130409
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea
- ClinicalTrials.gov ID
- NCT03959527
- Acronym / sponsor ID
- STI_Zoli001
- Conditions
- Gonorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Global Antibiotics Research and Development PartnershipUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 26 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single dose of Zoliflodacin or comparators combination in single dose: ceftriaxone and azithromycin
| Arm | Type | Receives |
|---|---|---|
| zoliflodacin | Experimental | Drug: zoliflodacinParticipant in this arm will receive a single dose of zoliflodacin. |
| ceftriaxone and azithromycin combination | Active comparator | Drug: ceftriaxone, Drug: azithromycinParticipant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance)
- Weight ≥ 35 kg
- Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture)
- For females of child-bearing potential, a negative urine pregnancy test at screening
- For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study.
Key exclusion criteria (19 listed)
- Confirmed or suspected complicated or disseminated gonorrhoea
- Pregnant or breastfeeding women
- Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
- Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
- Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening
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 |
|---|---|---|
| zoliflodacinDose: 3g, oral administration | Drug | zoliflodacin |
| ceftriaxoneDose: 500mg, Intra-Muscular (IM) administration | Drug | ceftriaxone and azithromycin combination |
| azithromycinDose: 1g, oral administration | Drug | ceftriaxone and azithromycin combination |
Primary outcome
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 6 (+/- 2)
Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at test of cure visit in micro-ITT (urogenital) analysis set
34 secondary outcomes
Safety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 30
Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 6
Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 6
The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 6
Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin
Time frame: Day 6
Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin
Time frame: Day 6
Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 6
Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 6
Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
Time frame: Day 6
Arithmetic Mean Plasma Concentration of Zoliflodacin
Time frame: 15 min - 1 hour
Arithmetic Mean Plasma Concentration of Zoliflodacin
Time frame: 2-2.5 h
Arithmetic Mean Plasma Concentration of Zoliflodacin
Time frame: 4.5 - 5h
Arithmetic Mean Plasma Concentration of Zoliflodacin
Time frame: 10 -12 h
Arithmetic Mean Plasma Concentration of Zoliflodacin
Time frame: 24 - 36 h
Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin
Time frame: Day 2
Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin
Time frame: Day 2
Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin
Time frame: Day 2
Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin
Time frame: Day 2
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)
Time frame: Day 1
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.
Time frame: Day 6
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline
Time frame: Day 1
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.
Time frame: Day 6
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline
Time frame: Day 1
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.
Time frame: Day 6
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline
Time frame: Day 1
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit
Time frame: Day 6
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline
Time frame: Day 1
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.
Time frame: Day 6
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline
Time frame: Day 1
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit
Time frame: Day 6
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline
Time frame: Day 1
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit
Time frame: Day 6
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline
Time frame: Day 1
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit
Time frame: Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41391465Luckey A, Balasegaram M, Barbee LA, Batteiger TA, Broadhurst H, Cohen SE, Delany-Moretlwe S, de Vries HJC, Dionne JA, Gill K, Kenyon C, Kittiyaowamarn R, Lewis D, Mueller JP, Naicker V, O'Brien S, O'Donnell JP, Phanuphak N, Spooner E, Srinivasan S, Taylor SN, Unemo M, Zwane Z, Hook EW 3rd; Zoliflodacin Phase 3 Study Group. Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial. Lancet. 2026 Jan 10;407(10524):147-160. doi: 10.1016/S0140-6736(25)01953-1. Epub 2025 Dec 11.
- Derived from this study: PubMed 38130409Jacobsson S, Golparian D, Oxelbark J, Kong FYS, Da Costa RMA, Franceschi F, Brown D, Louie A, Drusano G, Unemo M. Pharmacodynamics of zoliflodacin plus doxycycline combination therapy against Neisseria gonorrhoeae in a gonococcal hollow-fiber infection model. Front Pharmacol. 2023 Dec 7;14:1291885. doi: 10.3389/fphar.2023.1291885. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zoliflodacin, ceftriaxone and azithromycin in people with Gonorrhea, run by Global Antibiotics Research and Development Partnership at 17 sites in 5 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 10 inclusion and 19 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 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, South Africa, Thailand, Belgium, Netherlands. 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?
Yes. Results are posted in the registry (first posted 26 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin. (time frame: Day 6 (+/- 2)). 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 NCT03959527, which also lists 2 linked publications.
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 8 Oct 2025.