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Trial record 8 of 79 for:    "Gonorrhea"

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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Cempra Inc
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cempra Inc
ClinicalTrials.gov Identifier:
NCT02210325
First received: August 1, 2014
Last updated: July 7, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Uncomplicated Urogenital Gonorrhea Drug: solithromycin Drug: ceftriaxone Drug: azithromycin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cempra Inc:

Primary Outcome Measures:
  • 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. [ Time Frame: 7 days after treatment ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 7 days ]
    Adverse event frequency and severity will be compared between patients who received solithromycin and those who received ceftriaxone plus azithromycin

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

Estimated Enrollment: 300
Study Start Date: August 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02210325

Contacts
Contact: Jonathan Zenilman, MD jzenilm1@jhmi.edu

Locations
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21205
United States, Ohio
Completed
Cleveland, Ohio, United States, 44109
Suspended
Toledo, Ohio, United States, 43614
Australia, New South Wales
Completed
Sydney, New South Wales, Australia, 2000
Australia, Victoria
Completed
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
Cempra Inc
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Marcus Chen, MD, PhD Melbourne Sexual Health Centre
  More Information

Responsible Party: Cempra Inc
ClinicalTrials.gov Identifier: NCT02210325     History of Changes
Other Study ID Numbers: CE01-302
15-0091, HHSN272201300013 ( Other Grant/Funding Number: NIAID )
Study First Received: August 1, 2014
Last Updated: July 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cempra Inc:
gonorrhea
chlamydia
solithromycin

Additional relevant MeSH terms:
Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 17, 2017