Extended Antibiotics for Penile Prosthesis Infection

(CUPID Trial)

Overseen By Sarah Faris, MD

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: University of Chicago

Must not be taking: Antibiotics, Immunosuppressives

Disqualifiers: Urethral stricture, Neurogenic bladder, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 days

800 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used antibiotics in the past week or need antibiotics right before the study.

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

Ciprofloxacin has been shown to be highly effective against a wide range of bacteria, including those causing urinary tract and soft tissue infections, as well as in preventing infections after prostate surgery. It is more active than many other antibiotics and has been used successfully in cases where other treatments failed. ^{1 2 3 4 5}

Is ciprofloxacin generally safe for use in humans?

Ciprofloxacin is generally considered safe for use in humans, with adverse reactions occurring in 4.0%-8.0% of patients. Common side effects include nausea, vomiting, and dizziness, but these effects are usually reversible after stopping the medication. ^{6 7 8 9 10}

How does the extended antibiotics treatment for penile prosthesis infection differ from other treatments?

The extended antibiotics treatment for penile prosthesis infection is unique because it involves the use of an antibiotic-coated prosthesis, which includes a combination of rifampicin and monocycline, to prevent bacterial adhesion and reduce infection rates. This approach differs from traditional methods that rely solely on perioperative antibiotics or spraying the prosthesis with antibiotic solutions, which have not been as effective in eradicating infections. ^{11 12 13 14 15}

Research Team

Sarah Faris, MD

Principal Investigator

University of Chicago Department of Surgery

Eligibility Criteria

This trial is for males aged 35-90 with erectile dysfunction who are getting a specific penile prosthesis (AMS 700) and haven't used antibiotics in the last week. It's not for those with prior prostheses, urinary tract foreign bodies, urethral strictures, tuberculosis-related cystitis, recent chemotherapy, bladder surgery history or systemic neuromuscular diseases.

Inclusion Criteria

I am a man aged 35-90 with erectile dysfunction.

I am a male choosing a specific penile implant for erectile dysfunction as per guidelines.

Exclusion Criteria

I have had bladder inflammation due to Tuberculosis.

I have a condition like MS that affects bladder control.

Any protected population (i.e. Prisoners)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo penile prosthesis placement and receive either no post-operative oral antibiotics or 6 days of oral antibiotics

6 days

1 visit (in-person for surgery)

Follow-up

Participants are monitored for infection-related outcomes and other complications after penile prosthesis placement

12 months

Regular follow-up visits as per study protocol

Treatment Details

Interventions

• Augmentin
• Bactrim
• Ciprofloxacin
• Doxycycline

Trial Overview The study tests if taking oral antibiotics (Doxycycline, Augmentin, Bactrim or Ciprofloxacin) for an extra six days after implanting a penile prosthesis can reduce infection risk. Participants will receive one of these antibiotics to see which is most effective.

Participant Groups

Group I: No post-operative oral antibiotics Active Control 1 Intervention

Patients will only receive 24hr of IV peri-operative antibiotics

Group II: 6 days of oral antibiotics Active Control 4 Interventions

Patients will receive 24hr of IV peri-operative antibiotics and then 6 days of oral antibiotics

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Loyola University

Collaborator

Trials

161

Recruited

31,400+

Findings from Research

Ciprofloxacin demonstrated superior antibacterial activity compared to norfloxacin and nalidixic acid, being 2-8 times more effective than norfloxacin and 100 times more effective than nalidixic acid against a range of clinically important bacteria, based on tests with approximately 300 clinical isolates.

In mouse protection studies, ciprofloxacin was significantly more effective than other antibiotics like ampicillin and trimethoprim-sulfamethoxazole, showing rapid bactericidal action and excellent efficacy against Pseudomonas infections, with no observed cross-resistance to beta-lactam antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The in vitro and in vivo activity of ciprofloxacin. Zeiler, HJ., Grohe, K.[2022]

In a study of 518 patients undergoing transurethral surgery, a single 500 mg dose of ciprofloxacin was found to be effective in reducing post-operative bacteriuria, with only 3.3% of patients experiencing this complication compared to higher rates in the cefotaxime (4.8%) and placebo (7.0%) groups.

Ciprofloxacin demonstrated a favorable safety profile, with only 3% of patients reporting drug-related adverse events, suggesting it is a suitable prophylactic option for preventing infections after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery. Klimberg, IW., Malek, GH., Cox, CE., et al.[2013]

Cinoxacin is an effective new treatment for initial and recurrent bacterial urinary tract infections, showing rapid therapeutic concentrations in urine and greater activity against certain bacteria compared to similar drugs.

The drug has a favorable safety profile with infrequent adverse events, and initial studies suggest it may also be beneficial as a preventive treatment for women prone to recurrent urinary tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cinoxacin: mechanism of action, spectrum of activity, pharmacokinetics, adverse reactions, and therapeutic indications. Scavone, JM., Gleckman, RA., Fraser, DG.[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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The in vitro and in vivo activity of ciprofloxacin. [2022]

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

In vitro activities of moxifloxacin against 900 aerobic and anaerobic surgical isolates from patients with intra-abdominal and diabetic foot infections. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Use of ciprofloxacin in patients undergoing transurethral prostatic surgery. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Postprostatectomy orchitis: reduction in incidence using perioperative ceftriaxone and postoperative ciprofloxacin. [2017]

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

Malignant external otitis: treatment with fluoroquinolones. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery. [2013]

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

Cinoxacin: mechanism of action, spectrum of activity, pharmacokinetics, adverse reactions, and therapeutic indications. [2019]

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

Adverse effects of the fluoroquinolones. [2019]

9. Norway pubmed.ncbi.nlm.nih.gov

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

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

Zymar (Gatifloxacin 0.3%) shows excellent Gram-negative activity against Serratia marcescens and Pseudomonas aeruginosa in a New Zealand White rabbit keratitis model. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Antibiotic coating reduces penile prosthesis infection. [2022]

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

Antibacterial activity of antibiotic coated silicone grafts. [2017]

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

A randomized prospective comparison of antibiotic tissue levels in the corpora cavernosa of patients undergoing penile prosthesis implantation using gentamicin plus cefazolin versus an oral fluoroquinolone for prophylaxis. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Antibiotic patterns with inflatable penile prosthesis insertion. [2015]

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

AUA-recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis. [2023]