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

Uncomplicated Urogenital Gonorrhea Clinical Trial

— SOLITAIRE-U  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210325
• Other study ID #: CE01-302
• Secondary ID: 15-0091, HHSN272
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2014
• Last updated: September 8, 2017
• Start date: August 2014
• Est. completion date: February 22, 2017

Study information

• Verified date: September 2017
• Source: Cempra Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: February 22, 2017
• Est. primary completion date: February 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gonorrhea
• Uncomplicated Urogenital Gonorrhea

Intervention

Drug:
• solithromycin

• ceftriaxone

• azithromycin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cempra Inc	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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