Zoliflodacin in Uncomplicated Gonorrhoea | NCT03959527

ID	Type	Description	Link
2019-000990-22	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
zoliflodacin	Experimental	Participant in this arm will receive a single dose of zoliflodacin.	Drug: zoliflodacin
ceftriaxone and azithromycin combination	Active Comparator	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).	Drug: ceftriaxone Drug: azithromycin

Name	Type	Description	Arm Group Labels	Other Names
zoliflodacin	Drug	Dose: 3g, oral administration	zoliflodacin
ceftriaxone

Measure	Description	Time Frame
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	Day 6 (+/- 2)

Measure	Description	Time Frame
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)	Day 30

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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).

Exclusion Criteria:
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
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

Facility	Status	City	State	ZIP	Country	Contacts
Jefferson County Department of Health		Birmingham	Alabama	35233	United States
University of Alabama at Birmingham

PubMed Identifier	Type	Citation	Retractions
41391465	Derived	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.
38130409

ID	Title	Description
FG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
FG001	Ceftriaxone and Azithromycin Combination

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 12, 2023	Jun 28, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

micro-ITT (urogenital): all randomized participants who had a positive NG culture from the relevant anatomical site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin

Posted

Number

95% Confidence Interval

percentage of participants

Day 6 (+/- 2)

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000506 OG001238

Title

Denominators

Categories

Title	Measurements
	OG00090.9(88.1 to 93.3) OG00196.2(92.9 to 98.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Point estimate for the treatment difference in proportion of ceftriaxone/azithromycin combination and zoliflodacin with microbiological cure and 2-sided 95% CI calculated by Newcombe score method.					Risk Difference (RD)	5.31			2-Sided	95	1.38	8.65			95% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin		Non-Inferiority	A single oral 3 g dose of zoliflodacin would be considered as non-inferior to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin if the upper bound of the 2-sided 95% CI for the microbiological cure rate of the combination therapy minus zoliflodacin was less than 12% (prespecified non-inferiority [NI] margin for the primary endpoint).

Secondary

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)

The safety population included all randomized participants who received any part of trial treatment

Posted

Count of Participants

Participants

Day 30

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants

Secondary

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).

Micro-ITT (Pharyngeal) population: all randomized participants who had a positive NG culture from the pharyngeal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants

Secondary

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).

Micro-ITT (Rectal): all randomized participants who had a positive NG culture from the rectal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants

Secondary

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.

Clinical Cure population: all participants assigned male at birth included in the Micro-ITT (urogenital) population and who had at least one sign or symptom of urethral gonorrhea at baseline.

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants

Secondary

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

micro-ITT (Urogenital): all randomized participants who had a positive NG culture from the urogenital site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants

Secondary

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

micro-ITT (urogenital): all randomized participants who had a positive NG culture from the urogenital site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants

Secondary

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.

Of those participants included in the micro-ITT (Urogenital) analysis set (i.e., all randomized participants who had a positive NG culture from the urogenital site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin) (N=744), a total of 725 had a positive NG NAAT result at baseline

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts

Secondary

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.

Of those participants included in the micro-ITT (Pharyngeal) analysis set (N=81) (i.e., all randomized participants who had a positive NG culture from the pharyngeal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin), a total of 69 had positive pharyngeal NG NAAT result

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts

Secondary

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.

Of those participants included in the micro-ITT (Rectal) analysis set (N=114) (i.e., all randomized participants who had a positive NG culture from the rectal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin), a total of 103 had a positive NG NAAT result at baseline

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts

Secondary

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

Of the 23 participants included in the PK Population Set (all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained), quantifiable zoliflodacin concentrations were available for only 22 participants at this time point

Posted

Mean

Standard Deviation

ng/mL

15 min - 1 hour

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

Arithmetic Mean Plasma Concentration of Zoliflodacin

Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following a single oral dose administration of zoliflodacin 3 g

PK Population Set (all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained).

Posted

Mean

Standard Deviation

ng/mL

2-2.5 h

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

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

The PK population will include all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.

Posted

Mean

Standard Deviation

ng/mL

4.5 - 5h

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

Arithmetic Mean Plasma Concentration of Zoliflodacin

Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose zoliflodacin 3 g

Posted

Mean

Standard Deviation

ng/mL

10 -12 h

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Posted

Mean

Standard Deviation

ng/mL

24 - 36 h

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

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

PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

Day 2

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

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

PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

Day 2

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

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

PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Day 2

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

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

PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Day 2

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration

Units	Counts
Participants	OG000

Secondary

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)

Number of participants in urogenital micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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)

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 1

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Secondary

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

Number of participants in urogenital Micro-ITT without missing data for the specified visit

Posted

Mean

Full Range

mg/L

Day 6

ID	Title	Description
OG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
OG001	Ceftriaxone Plus Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG00042 events42 affected619 at risk EG00124 events24 affected308 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG00024 events24 affected619 at risk EG0017 events7 affected308 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG00015 events15 affected619 at risk EG00122 events22 affected308 at risk
Nausea	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG00016 events16 affected619 at risk EG00113 events12 affected308 at risk
Injection site pain	General disorders	MedDRA (26.0)	Systematic Assessment	EG0006 events5 affected619 at risk EG00138 events38 affected308 at risk
Neutrophil count decreased	Investigations	MedDRA (26.0)	Systematic Assessment	EG00021 events21 affected619 at risk EG00115 events15 affected308 at risk
Headache	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG00065 events61 affected619 at risk EG00115 events14 affected308 at risk
Dizziness	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG00021 events21 affected619 at risk EG0015 events5 affected308 at risk

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D015231	Sexually Transmitted Diseases, Bacterial
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D002439	Cefotaxime
D002505	Cephacetrile
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones

ID	Title	Description
BG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration
BG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Zoliflodacin	Participant in this arm will receive a single dose of zoliflodacin. zoliflodacin: Dose: 3g, oral administration	0	619	0	619	162	619
EG001	Ceftriaxone and Azithromycin Combination	Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). ceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration azithromycin: Dose: 1g, oral administration	0	308	0	308	107	308