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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking oral antibiotics for six additional days can reduce the risk of infection after a penile implant. Participants will either receive one day of antibiotics through an IV or continue with oral antibiotics (such as Augmentin, Bactrim, Ciprofloxacin, or Doxycycline) for six more days. The trial seeks men with erectile dysfunction who plan to receive a specific type of penile implant and do not have certain medical conditions, such as urinary tract issues or recent antibiotic use. The researchers aim to find a better way to prevent infections for those undergoing this procedure. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to pioneering medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that longer antibiotic treatments can reduce infections in penile implants. Infection rates for these procedures typically range from 1% to 3% in medical settings. One study found that applying antibiotics directly to the implant significantly lowered infection rates. Another study reported that a shorter course of antibiotics after surgery was very effective, with 92% of patients successfully treated after an infection. However, infections can still occur, as about 11% of patients experienced complications, nearly half of which were infections. Overall, antibiotics appear to reduce the risk of infection, but some risks remain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores whether extended oral antibiotics after penile prosthesis surgery can effectively reduce infection rates. Traditionally, patients receive only 24 hours of IV antibiotics post-surgery, but this trial tests an additional 6 days of oral antibiotics like Augmentin, Bactrim, Ciprofloxacin, or Doxycycline. This approach could provide a more robust defense against infections, potentially improving recovery outcomes and reducing complications associated with penile implants. By extending antibiotic coverage, researchers hope to find out if this protocol offers better protection than the current short-term antibiotic regimen.

What evidence suggests that this trial's treatments could be effective in reducing penile prosthesis infection?

Research has shown that using antibiotics with penile implants can help reduce infection rates. Infection rates typically range from 1% to 3% in practice. One study found that using antibiotics during surgery significantly lowered infections. Another study showed that implants with an antibiotic coating had fewer infections than those without. In this trial, some participants will receive only 24 hours of IV peri-operative antibiotics, while others will receive an additional 6 days of oral antibiotics. Taking oral antibiotics for a few extra days after surgery might further decrease the risk of infections. ^{1 2 3 6 7}

Who Is on the Research Team?

Sarah Faris, MD

Principal Investigator

University of Chicago Department of Surgery

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10773620/

Successful Conservative Therapy for Infected Penile Implants Infection rates vary from 0.6% to 8.9% for primary procedures, but are reported to be 1–3% in clinical practice [6,7]. Jarow noted an incidence of 13.3% ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002253471004752X

Long-Term Infection Outcomes After Original Antibiotic ... We previously reported a statistically significantly lower infection rate for original inflatable penile prostheses impregnated with antibiotic treatment with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11399021/

Perioperative infection prevention during inflatable penile ... IPP has excellent outcomes in the general population and patients undergoing prosthesis insertion after radical prostatectomy report ...

4. auajournals.org auajournals.org/doi/10.1097/01.ju.0000118245.66976.e1

EFFICACY OF ANTIBIOTIC IMPREGNATION OF ... The treated group showed a statistically significant decrease in penile prosthesis infection rates in original implants compared with noncoated implants.

5. academic.oup.com academic.oup.com/jsm/article/22/8/1531/8166174

Multicenter examination of contemporary penile prosthesis ... Regarding CHG dipping, 58% reported not using it, and 8.9% had stopped after prior use. Among 85 surgeons who ever used CHG, 8.2% observed ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2050116120300519

Penile Implant Infection: Experience With Expanded ... Our study demonstrates a successful salvage rate of 92% with a shortened course of postoperative antibiotics. Before salvage, 4 patients (15%) had hardware ...

7. tau.amegroups.org tau.amegroups.org/article/view/17337/html

Post-operative antibiotics following placement of a penile ... The authors identified an overall 30-day complication rate of 11%; of which 45% were infectious in etiology (1).