Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea

• ClinicalTrials.gov Identifier: NCT01591447
• Recruitment Status: Completed
• First Posted: May 4, 2012
• Last Update Posted: March 3, 2017
• Sponsor: Melinta Therapeutics, Inc.
• Information provided by (Responsible Party): Melinta Therapeutics, Inc.

Tracking Information

• First Submitted Date: May 2, 2012
• First Posted Date: May 4, 2012
• Last Update Posted Date: March 3, 2017
• Study Start Date: May 2012
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 2, 2012): The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative [ Time Frame: 3 to 9 days after study drug dosing ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 2, 2012)

• Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea [ Time Frame: One day after study drug dosing, and 3 to 9 days after study drug dosing ]
  Adverse event reporting, clinical laboratory evaluations
• The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline) [ Time Frame: 3 to 9 days after study drug dosing ]
• Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens [ Time Frame: 3 to 9 days after study drug dosing ]
• Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens [ Time Frame: 3 to 9 days after study drug dosing ]
• In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated [ Time Frame: Baseline and (if applicable) 3 to 9 days after study drug dosing ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
• Official Title: An Open-Label Study to Evaluate the Efficacy and Safety of a Single-Dose of Oral CEM-101 in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea
• Brief Summary: To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Uncomplicated Urogenital Gonorrhea

Intervention

• Drug: solithromycin
  A single oral dose of 1200 mg solithromycin (CEM-101)
• Drug: Solithromycin (CEM-101)
  A single oral dose of 1000 mg solithromycin

Study Arms

• Experimental: Solithromycin (CEM-101)
  A single oral dose of 1200 mg solithromycin
  Intervention: Drug: solithromycin
• Experimental: Solithromycin 1000 mg
  A single oral dose of 1000 mg solithromycin
  Intervention: Drug: Solithromycin (CEM-101)

• Publications *: Hook EW 3rd, Golden M, Jamieson BD, Dixon PB, Harbison HS, Lowens S, Fernandes P. A Phase 2 Trial of Oral Solithromycin 1200 mg or 1000 mg as Single-Dose Oral Therapy for Uncomplicated Gonorrhea. Clin Infect Dis. 2015 Oct 1;61(7):1043-8. doi: 10.1093/cid/civ478. Epub 2015 Jun 18.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 4, 2013): 60
• Original Estimated Enrollment (submitted: May 2, 2012): 30
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
2. Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
3. Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

1. Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
2. Known HIV, chronic hepatitis B, or hepatitis C infection.
3. Known concomitant infection which would require additional systemic antibiotics.
4. Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
5. Current use of corticosteroid drugs or other immunosuppressive therapy.
6. Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
7. Known significant renal, hepatic, or hematologic impairment.
8. History of intolerance or hypersensitivity to macrolide antibiotics.
9. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy <30 days).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01591447
• Other Study ID Numbers: CE01-202
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Melinta Therapeutics, Inc.
• Study Sponsor: Melinta Therapeutics, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Edward W Hook, MD; University of Alabama at Birmingham

• PRS Account: Melinta Therapeutics, Inc.
• Verification Date: March 2017