STI_Zoli001

A multi-center, randomized, open-label, noninferiority Trial to evaluate the efficacy and safety of a Single, oral dose of zoliflodacin compared to a Combination of a single intramuscular dose of Ceftriaxone and a single oral dose of azithromycin in the Treatment of patients with uncomplicated gonorrhoea

Rationale

There is growing concerns over progressive antimicrobial resistance and the development pipeline for uncomplicated gonorrhoea remains relatively empty with only two new chemical entities (NCE) currently in development: zoliflodacin and gepotidacin. Zoliflodacin (AZD0914) has shown extremely good activity against a large collection of isolates (standard and clinical), from different geographical origins, including multi-drug resistant (MDR) and extremely drug resistant (XDR) strains. Zoliflodacin has proven to be an excellent clinical candidate both in terms of efficacy and safety. The drug is well tolerated, can be administered orally and has shown high rates of cure for urethral, cervical and rectal gonococcal infection in phase II. In summary, zoliflodacin is a new promising option to address the risk posed by the threat of drug-resistant gonorrhoea. The purpose of this phase III multi-center, randomized, open-label, non-inferiority trial is to confirm the efficacy and safety outcomes observed in the phase II trial and to generate the necessary evidence to support a marketing authorization application in the USA, the European Union (EU), South Africa and Thailand.

Primary Objectives

To assess the efficacy of a single, oral, 3g dose of zoliflodacin compared to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated urogenital gonorrhoea

Study population

Sexually-active, HIV-uninfected adolescents (<18 years old at time of enrollment)

Investigators

IOR: Prof Sinead Delany-Moretlwe Sub Investigators: Dr Danielle Travill, Dr Jeanne Omony

Latest Update: 15 February 2021

For more about STI_Zoli001 please email rhicomms@wrhi.ac.za