CompletedPhase 4

Efficacy of Combination Therapies for Gonorrhea Treatment

United States614 participantsStarted 2010-06

Plain-language summary

The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However, some gonorrhea is not cured with a single antibiotic. The study will look at how well treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2 treatment groups each receiving a combination of 2 antibiotics. Sites in the United States will recruit 500 male and female participants. Participants must be 15 to 60 years old, in good health and identified in participating sexually transmitted disease clinics as having uncomplicated cervical or urethral gonorrhea. Procedures include collection of current symptoms, medical and sexual history, sexual orientation, vital signs, height, weight, cervical/urethral cultures and clinical examinations. Volunteers will be involved for about 17 days.

Who can participate

Age range

15 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Untreated male or female with urethral or cervical gonorrhea as determined by a screening laboratory test \[either Nucleic Acid Amplification Test (NAAT) or culture\] for Neisseria gonorrhoeae at a prior visit.
. Urethral or cervical gram stain demonstrating gram negative intracellular diplococci and leukocytes.
. Untreated male or female who is a sexual contact (anal, oral, or vaginal) of an individual with gonorrhea in the past 60 days.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection

Timeframe: 10-17 days after treatment.

Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection

Timeframe: 10-17 days after treatment.

Trial details

NCT IDNCT00926796

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2013-11-25

View on ClinicalTrials.gov More Gonorrhoea trials

Plain-language summary

Who can participate

Age range

15 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Untreated male or female with urethral or cervical gonorrhea as determined by a screening laboratory test \[either Nucleic Acid Amplification Test (NAAT) or culture\] for Neisseria gonorrhoeae at a prior visit.
. Urethral or cervical gram stain demonstrating gram negative intracellular diplococci and leukocytes.
. Untreated male or female who is a sexual contact (anal, oral, or vaginal) of an individual with gonorrhea in the past 60 days.

What they're measuring

Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection

Timeframe: 10-17 days after treatment.

Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection

Timeframe: 10-17 days after treatment.