Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea (SOLITAIRE-U)

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.

Study Overview

• Status: Completed
• Conditions: Uncomplicated Urogenital Gonorrhea
• Intervention / Treatment: Drug: solithromycin; Drug: ceftriaxone; Drug: azithromycin

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
  • Victoria
    • Melbourne, Victoria, Australia, 3053
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
  • Ohio
    • Cleveland, Ohio, United States, 44109
    • Toledo, Ohio, United States, 43614

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 1 of the following:

  1. 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.
  2. 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.
  3. 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ceftriaxone plus Azithromycin; A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin	Drug: ceftriaxone; Drug: azithromycin
Experimental: Solithromycin; A single oral dose of 1000 mg solithromycin	Drug: solithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	7 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.		7 days
To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.		21 days after treatment

Collaborators and Investigators

• Sponsor: Melinta Therapeutics, Inc.
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Marcus Chen, MD, PhD, Melbourne Sexual Health Centre

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): February 22, 2017
• Study Completion (Actual): February 22, 2017

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: gonorrhea; chlamydia; solithromycin
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Gonorrhea; Anti-Infective Agents; Anti-Bacterial Agents; Ceftriaxone; Azithromycin; Solithromycin
• Other Study ID Numbers: CE01-302; 15-0091, HHSN272201300013 (Other Grant/Funding Number: NIAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No