Zoliflodacin for Gonorrhea
Trial Summary
What is the purpose of this trial?
This trial is testing a new pill called zoliflodacin to see if it works as well as the current standard treatment for patients with uncomplicated gonorrhoea. The pill works by stopping the bacteria from growing, which helps to clear the infection. Zoliflodacin has shown promise in treating uncomplicated gonorrhea.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as antibiotics with activity against gonorrhea, systemic corticoid drugs, immunosuppressive therapy, and moderate or strong CYP3A4 inducers or inhibitors, at least 30 days before screening. If you're on any of these, you may need to stop them to participate.
What data supports the effectiveness of the drug Zoliflodacin for treating gonorrhea?
Is Zoliflodacin safe for humans?
What makes the drug Zoliflodacin unique for treating gonorrhea?
Zoliflodacin is unique because it is an oral antibiotic from a new class called spiropyrimidinetriones, which works by inhibiting bacterial enzymes in a way different from existing drugs. It is effective against drug-resistant strains of gonorrhea and offers a promising new option for treating this infection.257910
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of zoliflodacin or a combination of a single intramuscular dose of ceftriaxone and a single oral dose of azithromycin
Test of Cure
Participants are assessed for microbiological cure at urethral, cervical, rectal, and pharyngeal sites
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events
Treatment Details
Interventions
- Azithromycin
- Ceftriaxone
- Zoliflodacin
Azithromycin is already approved in European Union, United States, Canada for the following indications:
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Global Antibiotics Research and Development Partnership
Lead Sponsor