Sulopenem Etzadroxil + Probenecid for Bacterial Infections

Overseen By Senior Vice President and Head of Clinical Development

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Iterum Therapeutics, International Limited

Must not be taking: Carbapenems, Penicillin, Cephalosporins, Probenecid

Disqualifiers: Renal insufficiency, Severe sepsis, Liver disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for adolescents with bacterial infections. It tests whether a combination of two drugs, sulopenem etzadroxil (an antibiotic) and probenecid, is safe and tolerable for young patients. Researchers aim to understand how these drugs move through the body after administration. Adolescents with a diagnosed bacterial infection, already on antibiotics, may be suitable for this study. Participants must be comfortable providing blood and urine samples at various times. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Is there any evidence suggesting that sulopenem etzadroxil plus probenecid is likely to be safe for humans?

Research has shown that sulopenem etzadroxil combined with probenecid has been tested in nearly 3,000 people for other conditions, providing some understanding of its safety. The treatment is generally well-tolerated, with most side effects being mild, such as an upset stomach or diarrhea.

Other studies have demonstrated sulopenem's effectiveness in treating certain bacterial infections, like those caused by E. coli, indicating its potential in fighting infections. While sulopenem etzadroxil plus probenecid is considered safe for treating urinary tract infections in adults, this trial marks one of the first steps in testing it for teenagers. More information is needed to confirm its safety and efficacy specifically for teens. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sulopenem etzadroxil plus probenecid is unique because it combines a new oral antibiotic, sulopenem etzadroxil, with probenecid to enhance its effectiveness. Unlike standard treatments for bacterial infections, which often require intravenous administration, this combination is taken orally, potentially making it more convenient for patients. Researchers are excited about this treatment due to its broad-spectrum activity, which allows it to target a wide range of bacterial infections, thus offering a promising alternative to existing therapies.

What evidence suggests that sulopenem etzadroxil plus probenecid might be an effective treatment for bacterial infections?

Research has shown that sulopenem etzadroxil, when combined with probenecid, may effectively treat bacterial infections. One study found this combination worked in 61.7% of patients, outperforming the 55.0% success rate with Augmentin®. This suggests it might be more effective than some current antibiotics. Additionally, sulopenem etzadroxil has proven safe and effective for treating urinary tract infections (uUTIs) in adults. Although more research is needed, these early results are promising for its use against bacterial infections. Participants in this trial will receive a single oral dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid as a bilayer tablet. ^{1 4 5 6 7}

Who Is on the Research Team?

Senior Vice President and Head of Clinical Development

Principal Investigator

Iterum Therapeutics

Are You a Good Fit for This Trial?

This trial is for male and female adolescents aged 12 to under 18 with a bacterial infection confirmed by a doctor. They must be taking standard antibiotics, have good vein access for blood samples, and not be pregnant or breastfeeding. Postmenarchal females and post-pubertal males need to use effective birth control. Consent from parents/guardians and assent from the adolescent are required.

Inclusion Criteria

I am willing to follow all the study's procedures.

My guardian has agreed to the study, and I understand what is required of me.

I am between 12 and 17 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid, with blood and urine samples collected at specified timepoints

1 day

1 visit (in-person)

Follow-up

A safety follow-up to monitor for adverse events and assess safety and tolerability

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sulopenem Etzadroxil Plus Probenecid

Trial Overview The study tests sulopenem etzadroxil plus probenecid in teens with bacterial infections, focusing on safety, tolerability, and how the body processes these drugs. Participants will take one oral dose alongside their usual antibiotics; blood and urine will be collected at specific times to analyze drug movement.

How Is the Trial Designed?

Group I: Oral sulopenem Experimental Treatment 1 Intervention

Single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.

Who Is Running the Clinical Trial?

Iterum Therapeutics, International Limited

Lead Sponsor

Trials

8

Recruited

6,200+

Citations

1. academic.oup.com academic.oup.com/ajhp/advance-article/doi/10.1093/ajhp/zxaf220/8237645

Sulopenem etzadroxil and probenecid: A drug review of a ... Sulopenem is an effective and safe option for the treatment of uUTI in adult women. However, there is a lack of current research evidence to ...

2. iterumtx.com iterumtx.com/news/press-releases/detail/116/iterum-therapeutics-announces-positive-topline-results-from

Iterum Therapeutics Announces Positive Topline Results ... Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin®, demonstrating statistically significant superiority ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/213972Orig1s000IntegratedR.pdf

213972Orig1s000 - accessdata.fda.gov The following is an addendum to the Integrated Review for NDA 213972 (ORLYNVAH, sulopenem etzadroxil/probenecid) signed into DARRTS on 10/24/ ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07092813

Study Details | NCT07092813 | Pharmacokinetics of ... The goal of this clinical trial is to evaluate the use of sulopenem etzadroxil plus probenecid in adolescent patients being treated for bacterial infection.

5. urologytimes.com urologytimes.com/view/phase-3-data-of-oral-sulopenem-for-uutis-published-in-nejm-evidence

Phase 3 data of oral sulopenem for uUTIs published in ... Oral sulopenem demonstrated non-inferiority to amoxicillin/clavulanate in treating uUTIs, with a 60.9% success rate versus 55.6%. Statistically ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04700787

Safety, Tolerability, and Pharmacokinetics of Sulopenem in ... The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11907500/

Sulopenem Etzadroxil/Probenecid - PMC In clinical infections and in vitro, sulopenem has demonstrated activity against most isolates of E. coli, K. pneumoniae, and P. mirabilis.