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

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ClinicalTrials.gov Identifier: NCT02210325
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Uncomplicated Urogenital Gonorrhea Drug: solithromycin Drug: ceftriaxone Drug: azithromycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
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
Actual Study Start Date : August 2014
Actual Primary Completion Date : February 22, 2017
Actual Study Completion Date : February 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea

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



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

Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210325


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

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Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02210325     History of Changes
Other Study ID Numbers: CE01-302
15-0091, HHSN272201300013 ( Other Grant/Funding Number: NIAID )
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Melinta Therapeutics, Inc.:
gonorrhea
chlamydia
solithromycin

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