Trial record 8 of 59 for:    "Gonorrhea"

Randomized, Open-label Phase 2 Study of Oral AZD-0914 in the Treatment of Gonorrhea

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02257918
First received: September 19, 2014
Last updated: October 16, 2014
Last verified: September 2014
  Purpose

This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female subjects, between the ages of 18 and 55, who are in good health and meet all eligibility criteria. The study is designed to assess the safety and efficacy of an antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone. Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone.


Condition Intervention Phase
Gonorrhoea
Drug: Ceftriaxone
Drug: AZD0914
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of a Single Dose of Oral AZD0914 Compared to Intramuscular Ceftriaxone in the Treatment of Male and Female Subjects With Uncomplicated Gonorrhea

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The proportion of subjects with microbiological cure rate at urethral or cervical sites in each study arm [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
  • The proportion of subjects reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) considered product-related. [ Time Frame: Day 1 through Day 31 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects with microbiological cure rate at rectal sites in each study arm [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
  • The proportion of subjects with microbiological cure at pharyngeal sites in each study arm [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
  • The proportion of subjects with no detectable N. gonorrhoeae nucleic acid in urethral, cervical, rectum and pharynx specimen in each study arm [ Time Frame: Day 1 (Baseline) and Day 6 ] [ Designated as safety issue: No ]
  • The in vitro minimum inhibitory concentrations against AZD0914 and ceftriaxone of gonococcal isolates from culture [ Time Frame: Day 1 (Baseline) and Day 6 ] [ Designated as safety issue: No ]
  • The proportion of subjects with clinical cure in each study arm [ Time Frame: Day 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
N =70 subjects receive single oral dose , 3000 mg of AZD0914
Drug: AZD0914
AZD0914 manufactured by AstraZeneca is an amorphous non-sterile powder formulated as a powder for oral suspension. Group 1 receive 2000 mg oral dose and Group 2 receive 3000 mg oral dose.
Experimental: Group 1
N = 70 subjects receive single oral dose , 2000 mg of AZD0914
Drug: AZD0914
AZD0914 manufactured by AstraZeneca is an amorphous non-sterile powder formulated as a powder for oral suspension. Group 1 receive 2000 mg oral dose and Group 2 receive 3000 mg oral dose.
Active Comparator: Group 3
N = 40 subjects receive single intramuscular dose, 500 mg of ceftriaxone
Drug: Ceftriaxone
Ceftriaxone is a white to yellowish orange crystalline powder and contains approximately 83 mg of sodium per gram of ceftriaxone activity. Group 3 receive 500 mg intramuscular dose.

Detailed Description:

Uncomplicated gonorrhea is currently the second most common bacterial sexually transmitted infection (STI) worldwide and, accordingly, is a serious public health problem. This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female subjects, between the ages of 18 and 55, with uncomplicated cervical or urethral gonorrhea. The study is designed to assess the safety and efficacy of an antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to adults to treat uncomplicated urogenital gonorrhea compared to treatment with intramuscular ceftriaxone. Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The study duration is 7 months and subject participation of 30 days. Subjects with 1) untreated urethral or cervical gonorrhea identified via laboratory testing at a prior visit, or 2) untreated subjects acknowledging anal, oral, or vaginal sexual contact in the past 14 days with someone diagnosed with gonorrhea, or 3) signs and symptoms of urethral or cervical gonorrhea will be offered enrollment in the study and consented. The primary objective assess the efficacy by microbiological cure rate of 2000 mg or 3000 mg AZD0914 compared to 500 mg ceftriaxone for the treatment of uncomplicated urogenital gonorrhea. The second primary objective assess the safety and tolerability of a single oral dose of 200 mg or 3000 mg AZD0914 compared to 500 mg ceftriaxone in adult subjects with uncomplicated urogenital gonorrhea.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Untreated subjects with signs and symptoms of urethral or cervical gonorrhea, or urethral or cervical gonorrhea as defined by positive culture, NAAT test, Gram-stain or sexual contact with an infected individual in the past 14 days
  • Subject is able to give voluntary written informed consent before any study related procedure is performed

    -.Willingness to comply with all protocol requirements

  • Male or non-pregnant female 18 to 55 years of age, inclusive
  • If the subject is female, a negative urine pregnancy test at Visit 1 prior to receiving study drug
  • Subject willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for 7 days following study drug dosing to prevent potential gonococcal reinfection
  • Male heterosexual subjects must be surgically sterilized or use condoms with contraceptive jelly, cream or foam for 7 days following study drug dosing
  • Female subject must be of non-childbearing potential* or if of childbearing potential, she must be using a highly effective method of birth control**

    • Non-childbearing potential is defined as being post-menopausal for at least two years, status after bilateral oophorectomy or status after hysterectomy.

      • Female subjects must avoid becoming pregnant by using one of the following acceptable methods of birth control for 30 days prior to study drug dosing:

        • Intrauterine contraceptive device; OR
        • Oral contraceptives; OR
        • Implanon®,Nexplanon®, DepoProvera®, contraceptive skin patch or NuvaRing®, OR
        • Tubal ligation OR
        • Abstinence AND
        • for 30 days following dosing, any method above should be used plus the required use of a barrier method (condom) by the male partner (even if vasectomized)

Exclusion Criteria:

  • Confirmed or suspected, complicated or systemic gonorrhea such as pelvic inflammatory disease, testicular pain, epididymitis, arthritis, conjunctivitis or endocarditis
  • Known concomitant infection which would require immediate additional systemic antibiotics
  • Female subject currently breastfeeding
  • Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration
  • Use of systemic corticosteroid drugs or other immunosuppressive therapy within 30 days prior to enrollment
  • Cytotoxic chemotherapy or radiation therapy within the previous 3 months
  • Known chronic renal, hepatic (including chronic hepatitis B or hepatitis C infection) or hematologic impairment, or other condition that could interfere with the absorption or metabolism of the study drug
  • Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the course of therapy and follow-up could be completed
  • Subject known to be HIV positive
  • Known allergy to cephalosporin or penicillin antibiotics
  • Receipt or planned receipt of an investigational product in a clinical trial within 30 days prior to or 7 days after study dose administration
  • Female subject who tests positive for bacterial vaginosis at Visit 1 and does not agree to defer treatment until Visit 2
  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: NCT02257918

Contacts
Contact: Stephanie Taylor (504) 251-1611 staylo2@lsuhsc.edu

Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02257918     History of Changes
Other Study ID Numbers: 14-0014, HHSN272201300012I
Study First Received: September 19, 2014
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
urogenital gonorrhoea, AZD-0914, Ceftriaxone, antimicrobial, drug-resistant, antibiotic, sexually transmitted infection

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

ClinicalTrials.gov processed this record on October 21, 2014