NCT01591447

Brief Summary

To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

May 2, 2012

Last Update Submit

March 1, 2017

Conditions

Uncomplicated Urogenital Gonorrhea

Outcome Measures

Primary Outcomes (1)

  • The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative

    3 to 9 days after study drug dosing

Secondary Outcomes (5)

  • Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea

    One day after study drug dosing, and 3 to 9 days after study drug dosing

  • The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)

    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

    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

    3 to 9 days after study drug dosing

  • In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated

    Baseline and (if applicable) 3 to 9 days after study drug dosing

Study Arms (2)

Solithromycin (CEM-101)

EXPERIMENTAL

A single oral dose of 1200 mg solithromycin

Drug: solithromycin

Solithromycin 1000 mg

EXPERIMENTAL

A single oral dose of 1000 mg solithromycin

Drug: Solithromycin (CEM-101)

Interventions

solithromycinDRUG

A single oral dose of 1200 mg solithromycin (CEM-101)

Solithromycin (CEM-101)
Solithromycin (CEM-101)DRUG

A single oral dose of 1000 mg solithromycin

Solithromycin 1000 mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
  • Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms 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, arthritis, or endocarditis.
  • Known HIV, chronic hepatitis B, or hepatitis C infection.
  • Known concomitant infection which would require additional systemic antibiotics.
  • Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
  • Current use of corticosteroid drugs or other immunosuppressive therapy.
  • Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
  • Known significant renal, hepatic, or hematologic impairment.
  • History of intolerance or hypersensitivity to macrolide antibiotics.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jefferson County Department of Health

Birmingham, Alabama, 35233, United States

Location

Harborview STD Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 26089222DERIVED

MeSH Terms

Interventions

solithromycin

Study Officials

  • Edward W Hook, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 4, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

US(2)