Gonorrhea Treatment Market Size & Share, by Drug Class (Antibiotics, Combination Therapies); Treatment Type; Infection Type- Global Supply & Demand Analysis, Growth Forecasts, Statistical Report 2026-2035

Time
Slope over time before the pandemic

1.01

0.98, 1.05

Pandemic
Immediate level change after the pandemic

0.51

0.04, 7.22

Time and Pandemic
Slope Change after the pandemic

1.01

0.91, 1.13

ICD funding
Difference of rates with ICD funding

1.06

1.01, 1.11

ICD funding and time
Slope difference by ICD funding during pre-pandemic period

1.00

0.99, 1.00

Level change: ICD funding and pandemic
Immediate decrease post-pandemic onset per $increase in ICD funding

1.11

0.92, 1.33

Slope change: Time, Pandemic and ICD funding
Change in trend post-pandemic onset per $ increase in ICD funding

0.99

0.99, 1.00

Official title

A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae

Sponsor / Responsible party

GlaxoSmithKline (GSK)

Study type

Interventional (Clinical trial)

Phase

Phase 3

Design (overall)

Randomized, multicenter, open-label, parallel assignment

Allocation

Randomized

Primary purpose

Treatment

Condition / indication

Uncomplicated urogenital gonorrhea (Neisseria gonorrhoeae)

Interventions / arms

Experimental: Gepotidacin - oral: 3000 mg (4 × 750 mg tablets) at Baseline (Day 1) at site; second 3000 mg oral dose (4 × 750 mg) self-administered 10-12 hours later.
Active comparator: Ceftriaxone (IM) + Azithromycin (oral): single IM dose of ceftriaxone 500 mg at Baseline; azithromycin 1000 mg oral (2 × 500 mg) at Baseline.

Primary outcome measure

Number of participants with culture-confirmed bacterial eradication of N. gonorrhoeae from the urogenital site at the Test-Of-Cure (TOC) visit (Day 4-8). (Measured Baseline → TOC)

Key secondary outcome measures

Culture-confirmed bacterial eradication from rectal site (TOC Day 4-8); from pharyngeal site (TOC Day 4-8); number of participants with any TEAEs and any SAEs (up to 21 days); changes from baseline in hematology and clinical chemistry parameters; urinalysis results; vital signs.

Eligibility - Ages

≥ 12 years

Eligibility - Sexes

All sexes eligible

Enrollment (actual)

628 participants (actual)

Study start (actual)

2019-10-21

Primary completion (actual)

2023-10-10

Study completion (actual)

2023-10-10

Number of sites/ locations

51 locations (countries listed in record include: the U.S., Australia, Germany, Mexico, Spain, United Kingdom - multiple cities per country as provided)

Key exclusion examples

Current epididymitis/orchitis; suspected/confirmed Chlamydia trachomatis infection requiring treatment that cannot be postponed; BMI ≥40 or ≥35 with comorbidity; known hypersensitivity to study drugs; immunocompromised status; significant renal/hepatic impairment; recent investigational product exposure; QT prolongation or use of QT-prolonging drugs; pregnancy/breastfeeding.

Notable inclusion examples

Clinical suspicion of urogenital gonococcal infection (or recent positive culture/NAAT up to 5-7 days prior); willing to avoid sexual activity or use condoms through TOC; body weight >45 kg; able to give informed consent/assent.

Safety monitoring

TEAEs / SAEs captured up to 21 days; labs, urinalysis, vitals, ECG screening / QTc specification in exclusion criteria.

Results posted / dates

Results first submitted: 2024-05-01; Results first posted: 2024-05-30; Last update posted: 2024-05-30; Last verified: 2024-04

Regulatory / jurisdiction note

Studies a U.S. FDA-regulated drug product (record flag)

Other identifiers

Other Study ID Numbers: 116577; EudraCT Number: 2018-001780-23

Comments / additional notes (from record)

Open-label non-inferiority Phase 3 trial; comparator regimen used IM ceftriaxone 500 mg + azithromycin 1000 mg single doses; results and supporting documents (protocol, SAP) are available via the ClinicalTrials.gov record and sponsor data-sharing portal.

Study title (short)

Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea (ResistAZM)

Official title

An Open Label Randomized Controlled Trial Comparing the Effect of Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Neisseria gonorrhoeae on the Resistome

Sponsor / Responsible party

Institute of Tropical Medicine, Belgium

Study type

Interventional

Phase

Phase 4

Study status (from record)

Completed (Results posted) - last update posted 2024-08-02

Brief summary

Randomized controlled trial enrolling 42 men with N. gonorrhoeae at the ITM STI/HIV clinic; randomized 1:1 to ceftriaxone alone or ceftriaxone + azithromycin; follow-up at day 14 to assess cure and monitor microbiome/resistome. Primary outcome is difference in abundance of resistance-conferring genes in rectal microbiome at day 14.

Conditions

Neisseria gonorrhoeae (gonorrhea)

Other Study ID Numbers

ITM202101

Study start (actual)

2022-01-17

Primary completion (actual)

2022-05-09

Study completion (actual)

2022-05-09

Enrollment (actual)

42

Number of locations / country

1 location — Institute of Tropical Medicine, Antwerp, Belgium

Ages eligible

18 years and older

Sexes eligible

Male (inclusion: male sex at birth)

Healthy volunteers accepted?

No

Gender-based eligibility

Yes - inclusion restricted to male sex at birth

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple (Participant; Care Provider; Investigator; Outcomes Assessor)

Primary purpose

Supportive Care

Interventions / arms (details)

Arm 1 (Active Comparator - Rocephin): Ceftriaxone 1 g + lidocaine 35 mg, intramuscular injection (single dose).
Arm 2 (Active Comparator - Rocephin + Azithromycin): Ceftriaxone 1 g + lidocaine 35 mg IM injection (single dose) plus Azithromycin 2 g orally (single dose).

Primary outcome measure

Macrolide Resistance Determinants: Ratio of mean macrolide-resistance determinant read counts in day-14 anorectal samples between the Ceftriaxone/Azithromycin group and the Ceftriaxone group. Time frame: Day 14.

Key secondary outcome measures

Read count of resistance determinants for each non-macrolide antibiotic class (Day 14); acquisition of phenotypic resistance to azithromycin by N. gonorrhoeae in morbidostat upon exposure to commensal Neisseria DNA extracts from each treatment group (Day 0 and Day 14).

Inclusion highlights (from record)

Able and willing to provide written informed consent; male sex at birth; ≥ 18 years; confirmed diagnosis of urethritis, proctitis or pharyngitis due to N. gonorrhoeae (symptomatic or asymptomatic) by positive NAAT or (for urethritis) positive gram/methylene blue stain.

Exclusion highlights (from record)

Use of any macrolide antibiotics in previous 6 months; known contraindications/allergy to ceftriaxone, azithromycin or lidocaine; presence of other condition/other STI likely to require another antibiotic at enrollment as assessed by treating physician.

IPD sharing plan

No (Plan for Individual Participant Data: No)

Results reporting dates (from record)

Results first submitted: 2023-06-05; Results first submitted that met QC criteria: 2024-02-15; Results first posted: 2024-08-02; Last update posted: 2024-08-02; Last verified: 2024-02.

Notes / comments (from record)

Primary outcome focuses on resistome (macrolide resistance determinants) in anorectal samples at day 14; small RCT (n=42) designed to evaluate microbiome/resistome impact of adding azithromycin to ceftriaxone therapy.