Ciprofloxacin Assay for Gonorrhea

Overseen By Angela LeClair

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Doxycycline, Penicillin, Ceftriaxone

Disqualifiers: Urogenital symptoms, Antibiotic use, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

1800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well the SpeeDx Resistance Plus assay can guide treatment for gonorrhea, a bacterial infection. The focus is on using ciprofloxacin, an antibiotic, to treat individuals who test positive for a specific type of gonorrhea. Participants should be English-speaking, have internet access, and not show symptoms of sexually transmitted infections. The trial aims to determine if ciprofloxacin can be an effective treatment option in a clinic setting. As an unphased trial, it offers participants the opportunity to contribute to important research that could enhance treatment options for gonorrhea.

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 prior data suggests that the SpeeDx Resistance Plus assay is safe for guiding treatment of Neisseria gonorrhoeae?

Research shows that ciprofloxacin has treated gonorrhea since the mid-1980s. It belongs to the fluoroquinolone group of antibiotics and was once a top choice for this infection. However, many types of gonorrhea have become resistant to it over time.

Despite this resistance, ciprofloxacin is usually well-tolerated by those who can take it. Like most medications, it can cause side effects, but they are generally mild. Common side effects may include nausea, diarrhea, or dizziness.

The study uses a special test to determine if ciprofloxacin can work for patients with a specific type of gonorrhea. This could help in selecting the best treatment for each person. Always discuss any treatment concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ciprofloxacin is unique because it targets the gyrA wildtype strain of Neisseria gonorrhea, which is a specific genetic variation. Unlike some other antibiotics that may face resistance issues, ciprofloxacin can effectively treat strains that retain sensitivity to it. Researchers are excited because this approach could offer a more targeted treatment option, potentially leading to better outcomes for patients with this specific bacterial profile.

What evidence suggests that the SpeeDx Resistance Plus assay is effective for guiding treatment of gonorrhea?

Studies have shown that ciprofloxacin can effectively treat gonorrhea when the bacteria are not resistant. Research indicates that a single dose of oral ciprofloxacin can eliminate gonorrhea infections, particularly when the bacteria have a specific genetic makeup called gyrA wildtype. In this trial, participants who test positive for N. gonorrhea and have the gyrA wildtype will receive ciprofloxacin as part of the treatment arm. Past treatments demonstrated that ciprofloxacin reliably cleared infections when the bacteria were not resistant, meaning the drug could kill them at low concentrations. However, some strains of gonorrhea have developed resistance to ciprofloxacin, reducing its effectiveness in those cases. Overall, with resistance testing, ciprofloxacin remains a powerful option for treating gonorrhea. ^{5 6 7 8 9}

Who Is on the Research Team?

Lindley Barbee, MD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

I do not have any symptoms.

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ciprofloxacin

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.

How Is the Trial Designed?

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 United States, European Union, Canada, Switzerland for the following indications:

Approved in United States 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 European Union 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

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

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 review of approximately 30,000 patients, quinolone antibiotics showed an overall adverse reaction rate of 4.0%-8.0%, with gastrointestinal issues being the most common side effects, affecting 1.0%-5.0% of patients.

Most adverse effects were reversible upon stopping the medication and were not dose-dependent, suggesting that quinolones can be safely used when prescribed carefully, although ongoing monitoring for new side effects is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of the fluoroquinolones. Halkin, H.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8282307/

Resistance-Guided Treatment of Gonorrhea: A Prospective ... Resistance-guided treatment of N. gonorrhoeae infections with single-dose oral ciprofloxacin was highly efficacious.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33229966/

A Narrative Review of Clinical Treatment Outcomes ... Conclusions: Ciprofloxacin reliably eliminated gonococcal infections with MICs <0.125 μg/mL across anatomic sites. Molecular assays predicting ...

3. academic.oup.com academic.oup.com/jac/article/80/5/1213/8109803

The continuing evolution of antibiotic resistance in Neisseria ... Ciprofloxacin was introduced for the treatment of gonorrhoea in the mid-1980s. Initially used at a low dose (250 mg), following reports of ...

4. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-023-08938-x

Evaluating the efficacy of different antibiotics against Neisseria ... The objective of this study was to evaluate the efficacy changes of seven antibiotics in the treatment of N. gonorrhoeae by using Monte Carlo simulation

5. cdc.gov cdc.gov/gonorrhea/hcp/drug-resistant/index.html

Drug-Resistant Gonorrhea By 2006, nearly 14% of gonorrhea samples were resistant to ciprofloxacin. Ciprofloxacin resistance was present in all regions of the country ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8912267/

Characterization of a Neisseria gonorrhoeae Ciprofloxacin ... The fluoroquinolone class antibiotic ciprofloxacin was recommended by CDC's treatment guideline as the first-line treatment option for gonorrhea ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666776225001103

Antimicrobial resistance in Neisseria gonorrhoeae and its ... Azithromycin resistance (24.9%, 749/3008) and ciprofloxacin resistance (65.8%, 1980/3008) had increased (9.0% (284/3159) and 57.4% (1665/2884), respectively, in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12210901/

Neisseria gonorrhoeae antimicrobial susceptibility testing This study establishes the 96-well microtiter assay with Kellogg's supplement as a reliable and scalable tool for N. gonorrhoeae antimicrobial susceptibility ...

9. who.int who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea

Multi-drug resistant gonorrhoea In many countries, ciprofloxacin resistance is exceedingly high, azithromycin resistance is increasing and resistance or decreased ...