Ciprofloxacin Assay for Gonorrhea

Recruiting in Palo Alto (17 mi)

Overseen by Lindley Barbee, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

Must not be taking: Doxycycline, Penicillin, Ceftriaxone

Disqualifiers: Urogenital symptoms, Antibiotic use, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study aims to test the effectiveness of using of SpeeDx Resistance Plus assay to guide treatment of Neisseria gonorrhoeae (Ng) in a sexual health clinic setting.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used antibiotics in the last 2 weeks or are taking certain drugs for gonorrhea during the visit.

What data supports the effectiveness of the drug ciprofloxacin for treating gonorrhea?

Ciprofloxacin has been shown to be highly effective against Neisseria gonorrhoeae, the bacteria that causes gonorrhea, with most isolates being highly susceptible to the drug. However, there has been a drift in susceptibility, and high-level resistance has emerged, although treatment failure remains uncommon. ^{1 2 3 4 5}

Is ciprofloxacin generally safe for human use?

Ciprofloxacin is generally considered safe for human use, with most side effects being mild and reversible, such as nausea, vomiting, and dizziness. Serious side effects are rare, but can include allergic reactions and effects on the liver or heart. It is important to monitor for any adverse reactions during treatment. ^{6 7 8 9 10}

What makes the drug ciprofloxacin unique for treating gonorrhea?

Ciprofloxacin is unique for treating gonorrhea because it was initially highly effective against Neisseria gonorrhoeae, but over time, some resistance has developed. Despite this, it remains a recommended therapy in some regions, and its effectiveness is monitored through national surveillance programs. ^{3 5 11 12 13}

Research Team

Lindley Barbee, MD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for English-speaking individuals who can access the internet weekly and are asymptomatic. It's not for those in contact with syphilis, unwilling to wait for test results before treatment, on certain antibiotics during the visit, showing symptoms of STIs (except some vaginitis), allergic to ciprofloxacin/ceftriaxone, or have taken antibiotics in the last 2 weeks.

Inclusion Criteria

English speaking

Have access to the internet (via computer or phone) on at least a weekly basis

I do not have any symptoms.

Exclusion Criteria

I have not taken antibiotics in the last 2 weeks.

I do not have symptoms of a sexually transmitted infection other than vaginitis.

I have been exposed to syphilis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Specimen Collection and Testing

Specimens are collected from anatomical sites of exposure for NAAT and culture. NAAT specimens positive for Ng are further tested with SpeeDx Resistance Plus assay.

1 day

1 visit (in-person)

Treatment

Participants who are N. gonorrhoeae positive and gyrA WT receive ciprofloxacin 500 mg PO x 1. Participants with gyrA s91 mutation return for standard of care.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including test of cure results.

2 years

Treatment Details

Interventions

• Ciprofloxacin (Fluoroquinolone Antibiotic)

Trial Overview The study tests if using SpeeDx Resistance Plus assay can effectively guide treatment of gonorrhea at a sexual health clinic. Participants will be given Ciprofloxacin 500 mg based on their test results from this new method.

Participant Groups

Group I: N. gonorrhea (gyrA wildtype) -Ciprofloxacin Treatment Arm Experimental Treatment 1 Intervention

Participants who are N. gonorrhea (NG) positive and gyrA WT, will receive ciprofloxacin 500 mg PO x 1.

Ciprofloxacin is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Cipro for:

• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Intra-abdominal infections
• Certain types of infectious diarrhea
• Typhoid fever

Approved in Switzerland as Ciprofloxacin for:

• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Intra-abdominal infections
• Certain types of infectious diarrhea
• Typhoid fever

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Findings from Research

Ciprofloxacin was effective in treating infectious complications in 65 patients, achieving good and satisfactory results in 67.7% and 20% of cases, respectively, and was effective against various infections including sepsis and respiratory infections.

The drug demonstrated a broad antibacterial spectrum, with 96.3% of resistant bacterial isolates being sensitive to it, and it can be administered both orally and intravenously, although 7.7% of patients experienced adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ciprofloxacin in the treatment of infections in oncology patients]. Dronova, OM.[2016]

Ciprofloxacin is an effective antibiotic for treating a variety of infections, including osteomyelitis, gonorrhea, and infections of the urinary and gastrointestinal tracts, with data from 2,018 patients showing its broad-spectrum activity against multiple bacteria.

In controlled trials, ciprofloxacin demonstrated comparable or superior safety and efficacy compared to other antibiotics like trimethoprim-sulfamethoxazole and ampicillin, with mild adverse reactions and rare emergence of resistance, making it a reliable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and potential economic benefits of oral ciprofloxacin in the treatment of infections. Sanders, WE.[2019]

Both ofloxacin and ciprofloxacin are effective against a wide range of clinical bacterial isolates, including methicillin-resistant Staphylococcus aureus and various intestinal pathogens, indicating their broad-spectrum efficacy.

Ciprofloxacin demonstrated greater activity than ofloxacin against Pseudomonas species, particularly showing effectiveness against most isolates of Pseudomonas aeruginosa and Pseudomonas fluorescens, while Pseudomonas cepacia was resistant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative in vitro antibacterial activity of ofloxacin and ciprofloxacin against some selected gram-positive and gram-negative isolates. Chau, PY., Leung, YK., Ng, WW.[2019]

In a study of 673 Neisseria gonorrhoeae isolates from a sexually transmitted diseases clinic, 39 showed decreased susceptibility to the antibiotics ciprofloxacin and ofloxacin, indicating a potential issue with antibiotic resistance.

The study found that other quinolones, such as BAY y 3118, DU-6859a, and clinafloxacin, had higher minimum inhibitory concentrations (MICs) against these resistant strains, suggesting that diminished susceptibility to one quinolone may indicate reduced effectiveness of others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activities of three investigational fluoroquinolones (BAY y 3118, DU-6859a, and clinafloxacin) against Neisseria gonorrhoeae isolates with diminished susceptibilities to ciprofloxacin and ofloxacin. Carlyn, CJ., Doyle, LJ., Knapp, CC., et al.[2021]

Ciprofloxacin remains a highly effective first-line treatment for gonorrhea, with the majority of tested isolates showing high susceptibility; however, a trend towards reduced susceptibility was observed between 1993 and 1996.

The study identified 18 isolates with potential resistance, primarily from patients who acquired infections abroad, indicating that while treatment failures are rare, increased ciprofloxacin use may be contributing to emerging resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drift in susceptibility of Neisseria gonorrhoeae to ciprofloxacin and emergence of therapeutic failure. Ison, CA., Woodford, PJ., Madders, H., et al.[2020]

Ciprofloxacin and ofloxacin, two fluoroquinolone antibiotics, are effective against most Gram-negative bacteria and are primarily used to treat recurrent urinary tract infections, gonorrhea, and serious gastrointestinal infections.

While they have a relatively low cross-resistance with other antibiotics, there is a notable risk of resistance developing in certain bacteria like Pseudomonas and Staphylococci, and about 10% of patients may experience gastrointestinal or central nervous system side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fluoroquinolones--a new and important group of antimicrobial agents]. Sander, J.[2013]

Ciprofloxacin is generally well tolerated with a low incidence of adverse events, while other fluoroquinolones like sparfloxacin and grepafloxacin have higher rates of serious side effects, including phototoxicity and gastrointestinal intolerance.

Fluoroquinolones can interact with other medications, particularly those metabolized by the liver, which can affect drug clearance; therefore, careful monitoring of drug interactions is essential when prescribing these antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the new fluoroquinolones compared with ciprofloxacin. Ball, P.[2019]

In a review of over 6500 patients, the overall incidence of adverse reactions to ciprofloxacin was low, ranging from 3.0% in Europe to 13.4% in the USA, with most reactions being mild and not requiring treatment withdrawal.

The most common side effects were gastrointestinal issues like nausea and diarrhea (2-8% of patients), while serious adverse effects were rare, with only three cases of significant toxicity reported, indicating that ciprofloxacin has an excellent safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciprofloxacin: an overview of adverse experiences. Ball, P.[2019]

Fluoroquinolone antibiotics generally have a favorable safety profile with mostly mild and reversible side effects, but postmarketing studies have revealed severe adverse events linked to some newer agents, leading to market withdrawals or restrictions due to serious risks like liver toxicity.

While older fluoroquinolones like ciprofloxacin and levofloxacin have not shown significant severe adverse events, caution is warranted with newer agents like moxifloxacin and gatifloxacin, as their long-term safety data is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety profile of the fluoroquinolones. Bertino, J., Fish, D.[2006]

In a study of 852 clinical isolates, ciprofloxacin was found to be the most effective quinolone antibiotic, followed by ofloxacin, while lomefloxacin and fleroxacin showed similar activity, particularly against most tested bacterial species.

Despite ciprofloxacin's in vitro advantages, the overall susceptibility patterns indicated a high degree of cross-susceptibility and cross-resistance among the quinolones, suggesting that if one quinolone is effective, others are likely to be as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of frequency distribution curves, scattergrams and regression analyses to compare in vitro activities and describe cross-susceptibility and cross-resistance among four quinolones. Fass, RJ.[2019]

Between 1997 and 1999, 4.8% of antibiotic-resistant Neisseria gonorrhoeae isolates in Canada were found to be ciprofloxacin-resistant, indicating a notable presence of CipR strains in the population.

The study identified specific mutations in the gyrA and parC genes associated with ciprofloxacin resistance, demonstrating that these strains are diverse and likely imported, highlighting the need for ongoing surveillance and advanced detection methods like DNA microarray technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of ciprofloxacin resistance in Neisseria gonorrhoeae isolates in Canada. Ng, LK., Sawatzky, P., Martin, IE., et al.[2019]

In a study involving 100 male adults with acute gonococcal urethritis, a single dose of 100 mg ciprofloxacin was found to be effective, with 99 out of 100 patients achieving clinical and bacteriological cure.

The treatment was well-tolerated with no reported side effects, suggesting that ciprofloxacin is a safe and effective option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciprofloxacin in acute male gonorrhea. Szarmach, H., Weuta, H., Podziewski, J., et al.[2013]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Ciprofloxacin in the treatment of infections in oncology patients]. [2016]

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

Efficacy, safety, and potential economic benefits of oral ciprofloxacin in the treatment of infections. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparative in vitro antibacterial activity of ofloxacin and ciprofloxacin against some selected gram-positive and gram-negative isolates. [2019]

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

Activities of three investigational fluoroquinolones (BAY y 3118, DU-6859a, and clinafloxacin) against Neisseria gonorrhoeae isolates with diminished susceptibilities to ciprofloxacin and ofloxacin. [2021]

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

Drift in susceptibility of Neisseria gonorrhoeae to ciprofloxacin and emergence of therapeutic failure. [2020]

6. Norway pubmed.ncbi.nlm.nih.gov

[Fluoroquinolones--a new and important group of antimicrobial agents]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Safety of the new fluoroquinolones compared with ciprofloxacin. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Ciprofloxacin: an overview of adverse experiences. [2019]

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

Adverse effects of the fluoroquinolones. [2019]

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

The safety profile of the fluoroquinolones. [2006]

11. England pubmed.ncbi.nlm.nih.gov

Use of frequency distribution curves, scattergrams and regression analyses to compare in vitro activities and describe cross-susceptibility and cross-resistance among four quinolones. [2019]

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

Characterization of ciprofloxacin resistance in Neisseria gonorrhoeae isolates in Canada. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

Ciprofloxacin in acute male gonorrhea. [2013]