Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
Condition: Gonorrhoea
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      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. The drug name is
      also known as ETX0914.
    

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 11 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. The drug name is also
      known as ETX0914.
    

Intervention name(s): AZD0914; Ceftriaxone
Intervention type(s): Drug; Drug
Intervention description(s): AZD0914 is an antimicrobial amorphous nonsterile powder. Group 1 receive 2000 mg; Group 2 receive 3000 mg. The drug name is also known as ETX0914.; Ceftriaxone is a broad-spectrum cephalosporin antibiotic with a very long half-life and high penetrability to meninges, eyes and inner ears. A white to yellowish orange crystalline powder. Group 3 receives 500 mg reconstituted with 1 ml Lidocaine HCL 1%, intramuscularly.
Intervention MeSH terms: Ceftriaxone; Zoliflodacin
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: antibiotic; antimicrobial; AZD0914; Ceftriaxone; drug-resistant; sexually transmitted infection; urogenital gonorrhoea