Clinical trial NCT01591447: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Urogenital Gonorrhea
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative
timeFrame: 3 to 9 days after study drug dosing
Secondary outcomes:
measure: Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea
timeFrame: One day after study drug dosing, and 3 to 9 days after study drug dosing
measure: The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline)
timeFrame: 3 to 9 days after study drug dosing
measure: Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens
timeFrame: 3 to 9 days after study drug dosing
measure: Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens
timeFrame: 3 to 9 days after study drug dosing
measure: In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated
timeFrame: Baseline and (if applicable) 3 to 9 days after study drug dosing
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Jefferson County Department of Health
state: Alabama
city: Seattle
country: United States
facility: Harborview STD Clinic
state: Washington
Study officials:
affiliation: University of Alabama at Birmingham
name: Edward W Hook, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.