Zoliflodacin for Gonorrhea

Recruiting at 19 trial locations

Overseen By Seamus O’brien

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Global Antibiotics Research and Development Partnership

Must not be taking: Antibiotics, Corticoids, CYP3A4 inducers, others

Disqualifiers: Pregnancy, Breastfeeding, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

1011 Participants Needed

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?

Research shows that Zoliflodacin is highly effective in lab tests against gonorrhea bacteria from Thailand and South Africa, with no resistance found to other common antibiotics, supporting its potential use in treating gonorrhea. ^{1 2 3 4 5}

Is Zoliflodacin safe for humans?

Zoliflodacin is a new antibiotic currently in clinical trials for treating gonorrhea, and while it shows promise, there is limited safety data available specifically for humans. However, it is being tested in a global phase 3 trial, which suggests ongoing evaluation of its safety profile. ^{2 6 7 8 9}

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. ^{2 5 7 9 10}

Eligibility Criteria

Inclusion Criteria

For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment

Willingness to comply with trial protocol

Willingness to undergo HIV testing

Exclusion Criteria

Severe medical or psychiatric condition which, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of trial results or affect the individual's ability to provide informed consent

Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug based on medical history and physical examination

History of urogenital sex-reassignment surgery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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

1 day

1 visit (in-person)

Test of Cure

Participants are assessed for microbiological cure at urethral, cervical, rectal, and pharyngeal sites

6 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events

30 days

Treatment Details

Interventions

• Azithromycin
• Ceftriaxone
• Zoliflodacin

Participant Groups

Group I: zoliflodacin Experimental Treatment 1 Intervention

Participant in this arm will receive a single dose of zoliflodacin.

Group II: ceftriaxone and azithromycin combination Active Control 2 Interventions

Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).

Azithromycin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Azithromycin for:

• Respiratory tract infections
• Skin and soft tissue infections
• Sexually transmitted diseases
• Toxoplasmosis
• Malaria
• Preterm prelabor rupture of membranes

Approved in United States as Azithromycin for:

• Respiratory tract infections
• Skin and soft tissue infections
• Sexually transmitted diseases
• Toxoplasmosis
• Malaria
• Preterm prelabor rupture of membranes

Approved in Canada as Azithromycin for:

• Respiratory tract infections
• Skin and soft tissue infections
• Sexually transmitted diseases
• Toxoplasmosis
• Malaria
• Preterm prelabor rupture of membranes

Who Is Running the Clinical Trial?

Global Antibiotics Research and Development Partnership

Lead Sponsor

Trials

2

Recruited

1,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Retreatment rates for uncomplicated gonorrhea infection: comparing ceftriaxone and azithromycin versus ceftriaxone and doxycycline. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Using a public database of Neisseria gonorrhoeae genomes to detect mutations associated with zoliflodacin resistance. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Primary Care Physician Knowledge of the Recommended Regimen for Treating Gonorrhea. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Gonococci change more quickly than prescribing practices; resistance to frequently prescribed antibiotics]. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

High in vitro susceptibility to the first-in-class spiropyrimidinetrione zoliflodacin among consecutive clinical Neisseria gonorrhoeae isolates from Thailand (2018) and South Africa (2015-2017). [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Safety Aspects and Rational Use of Single Intramuscular Dose Ceftriaxone: Clinical Insights on the Management of Uncomplicated Gonococcal Infections. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Complete Reference Genome Sequence of the Clinical Neisseria gonorrhoeae Strain H035, with Resistance to the Novel Antimicrobial Zoliflodacin, Identified in Japan in 2000. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Antimicrobial Resistance in Neisseria gonorrhoeae and Treatment of Gonorrhea. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Single-Dose Zoliflodacin (ETX0914) for Treatment of Urogenital Gonorrhea. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Zoliflodacin: An Oral Spiropyrimidinetrione Antibiotic for the Treatment of Neisseria gonorrheae, Including Multi-Drug-Resistant Isolates. [2021]