Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

NCT02210325 | Completed Phase 3

• 2 other identifiers: CE01-30215-0091, HHSN272201300013
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 5

Brief 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. 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

Keywords

gonorrhea; chlamydia; solithromycin

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

Study Arms (2)

Ceftriaxone plus Azithromycin

ACTIVE COMPARATOR

A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin

Drug: ceftriaxone; Drug: azithromycin

Solithromycin

EXPERIMENTAL

A single oral dose of 1000 mg solithromycin

Drug: solithromycin

Interventions

solithromycin DRUG

Solithromycin

ceftriaxone DRUG

Ceftriaxone plus Azithromycin

azithromycin DRUG

Ceftriaxone plus Azithromycin

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (5)

Unknown Facility

Baltimore, Maryland, 21205, United States

Location

Unknown Facility

Cleveland, Ohio, 44109, United States

Location

Unknown Facility

Toledo, Ohio, 43614, United States

Location

Unknown Facility

Sydney, New South Wales, 2000, Australia

Location

Unknown Facility

Melbourne, Victoria, 3053, Australia

Location

Related Publications (1)

• 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.

  PMID: 31196813 DERIVED

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections

Interventions

solithromycin; Ceftriaxone; Azithromycin

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Marcus Chen, MD, PhD

  Melbourne Sexual Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 6, 2014
• Study Start: August 1, 2014
• Primary Completion: February 22, 2017
• Study Completion: February 22, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); AU (2)