Could a single pill replace the shot for gonorrhea?
NCT ID NCT03959527
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tested a new antibiotic called zoliflodacin, taken as a single oral dose, against the standard treatment of an injection plus pills for uncomplicated gonorrhea. Over 1,000 participants were enrolled to see if the new pill works as well and is safe. If successful, it could offer a simpler, more convenient treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zoliflodacin
- What this could lead to
- If successful, this could provide a simple, single-dose oral treatment for gonorrhea, reducing the need for injections and helping fight antibiotic resistance.
- What could go wrong
- The trial is completed but results are not yet widely available. The new drug may not be as effective as current treatments, and antibiotic resistance remains a concern.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,011 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Sep 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance) 2. Weight ≥ 35 kg 3. Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture) 4. For females of child-bearing potential, a negative urine pregnancy test at screening 5. For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study. 6. For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment 7. Willingness to comply with trial protocol 8. Willingness to undergo HIV testing 9. Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit 10. Willingness and ability to give written informed consent or be consented by a legal representative or provide assent and parental consent (for minors, as appropriate). Exclusion Criteria: 11. Confirmed or suspected complicated or disseminated gonorrhoea 12. Pregnant or breastfeeding women 13. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection) 14. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening 15. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening 16. Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is greater, prior to screening 17. Cytotoxic or radiation therapy within 30 days prior to screening 18. 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 19. History of urogenital sex-reassignment surgery 20. Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count \<200 cells/μL 21. Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation 22. Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics 23. Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments) 24. Receipt or planned receipt of an investigational product in a clinical trial within 30 days or five half-lives of the drug, whichever is greater, prior to screening until end of participation to this clinical trial 25. History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator 26. 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 27. Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol 28. Previous randomisation in this clinical trial. 29. Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bangrak STI Center
Bangkok, 10120, Thailand
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Bell Flower Clinic
Indianapolis, Indiana, 46202, United States
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Institute of HIV Research and Innovation
Bangkok, 10330, Thailand
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Institute of Tropical Medicine
Antwerp, 2000, Belgium
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Jefferson County Department of Health
Birmingham, Alabama, 35233, United States
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Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
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Masiphumelele Research Site
Cape Town, 7975, South Africa
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Ndlovu Research Centre
Elandsdoorn, 0470, South Africa
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Public Health - Seattle & King County STD Clinic
Seattle, Washington, 98104, United States
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Public Health Service (GGD) Amsterdam / STI Outpatient Clinic
Amsterdam, 1018 WT, Netherlands
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SAMRC Botha's Hill Clinical Research Site
Bothas Hill, 3660, South Africa
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SAMRC Tongaat Clinical Research Site
Tongaat, 4400, South Africa
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San Francisco Department Of Public Health City Clinic
San Francisco, California, 94103, United States
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Setshaba Research Centre
Soshanguve, 0152, South Africa
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Silom Community Clinic
Bangkok, 10400, Thailand
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University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006, United States
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Wits RHI
Johannesburg, 2001, South Africa
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