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Can a few extra pills prevent implant infections?

NCT ID NCT05100654

Disease control Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether taking oral antibiotics for 6 extra days after getting a penile implant can lower the chance of infection. Researchers are following 800 men for one year after surgery. The goal is to see if this simple step reduces the need for another surgery to remove an infected implant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral antibiotics (doxycycline, ciprofloxacin, augmentin, or bactrim)
What this could lead to
If successful, this could show that a short course of oral antibiotics after surgery helps prevent infections, potentially improving outcomes for men with penile implants.
What could go wrong
This is an early-phase study, so results are preliminary. The antibiotics may not reduce infection risk, and side effects like upset stomach or allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 90 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males aged 35 to 90 yo with no racial or ethnic restrictions and a diagnosis of erectile dysfunction. 2. Males clinically indicated for de-novo InhibiZonetm coated AMS 700 devices IPP placement procedure per local clinical guidelines who have elected to pursue penile prosthesis as an ED treatment. Exclusion Criteria: 1. Patients with indwelling foreign body in the urinary tract \> 24 hours prior to the procedure (i.e. foley catheter). Patients using clean intermittent catheterization will not be excluded. 2. Prior history of or current symptomatic urethral stricture. 3. History of cystitis caused by Tuberculosis. 4. Active Cytoxan/cyclophosphamide therapy or immunosuppressive systemic chemotherapy. 5. Prior augmentation cystoplasty or cystectomy. 6. Systemic neuromuscular disease known to affect the lower urinary tract such as Spinal Cord Injury, Multiple Sclerosis or other condition leading to neurogenic bladder. 7. Antibiotic use within the past 1 week or need for antibiotic management immediately prior to the study. 8. Cases where patients have had a prior penile prosthesis. 9. Any protected population (i.e. Prisoners)

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Conditions

The condition(s) this trial relates to.

erectile dysfunction prosthesis-related infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction Penile prosthesis infection

Contacts and locations

Locations

  • University of Chicago

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.