Not recruiting

Title: Comparison of oral tebipenem pivoxil versus intravenous imipenem-cilastatin in adults with complicated urinary tract infection or acute pyelonephritis

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with complicated urinary tract infection or acute pyelonephritis, which are serious infections affecting the urinary system. The research compares two medications: tebipenem pivoxil hydrobromide, which is taken by mouth as tablets, and imipenem-cilastatin, which is given through a vein. One group of patients will receive tebipenem pivoxil tablets while another group will receive imipenem-cilastatin through an intravenous line. Some patients will also receive placebo tablets.

The purpose of this research is to determine how well oral tebipenem pivoxil works compared to intravenous imipenem-cilastatin in treating these urinary tract infections. The study will measure whether the infections are cured and if the bacteria causing the infections are eliminated. The medications will be given to adult patients who are in the hospital.

During the study, patients will receive treatment for up to 10 days. The study team will monitor patients' symptoms and take urine samples to check if the infection is responding to treatment. They will also check for any side effects from the medications. After the treatment period ends, patients will have follow-up visits to ensure the infection has been properly treated.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive either oral tebipenem pivoxil tablets or intravenous (IV) imipenem-cilastatin for your urinary tract infection or kidney infection.
The medical team will monitor your body temperature, urinary symptoms, and overall health condition.
If you have a urinary catheter in place for more than 24 hours, it will need to be changed before starting treatment.
Step 2
During treatment monitoring
Regular urine samples will be collected to check the effectiveness of treatment.
Blood tests will be performed to monitor kidney function and other health indicators.
Your vital signs, including temperature and any side effects, will be regularly checked.
Step 3
End of treatment evaluation
The medical team will assess if your infection has been cured.
A urine sample will be taken to confirm the infection has cleared.
Any remaining symptoms will be evaluated.
Step 4
Test-of-Cure visit
This is a follow-up visit to confirm the infection has been completely cleared.
Additional urine tests will be performed.
Your overall health status will be evaluated.
Step 5
Final follow-up
A final check will be performed to ensure the infection has not returned.
Any lasting effects or new symptoms will be documented.
This visit completes your participation in the study.

Who can join the trial?

13 criteria

Must be at least 18 years old (if in India, must be 90 years or younger)
Must be able to provide informed consent
Must be able to swallow tablets for the duration of treatment. Any nausea or vomiting should be mild or controlled with anti-nausea medication
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Must have a diagnosis of either:
- Complicated urinary tract infection (cUTI) with symptoms like fever, pain during urination, frequent urination, nausea, abdominal pain, AND at least one risk factor such as urinary catheter, kidney problems, or urinary tract abnormalities
- OR Acute pyelonephritis (kidney infection) with sudden flank pain and at least one symptom like fever, high white blood cell count, nausea, or painful urination
- Must have evidence of urinary infection shown by increased white blood cells in urine test
- Must be expected to survive with appropriate antibiotic treatment
- Must be willing to follow all study procedures
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  Must agree to use effective birth control methods:
  - Men must use barrier contraception
  - Women must either abstain from sexual activity or use approved contraceptive methods (hormonal contraceptives, IUD, or partner vasectomy)
  - Women who cannot bear children must prove their status through either:
    
    No menstrual periods for at least 12 months
    Specific hormone test results
    Previous sterilization surgery

Who cannot join the trial?

15 criteria

Age below 18 years
Known allergic reactions to any of the study medications
Presence of indwelling urinary catheter (a tube inserted into the bladder to drain urine)
Pregnancy or breastfeeding
Having severe kidney problems (severe renal impairment)
Having severe liver problems (severe hepatic impairment)
Current participation in other clinical trials
Having uncomplicated urinary tract infection (simple bladder infection)
Having conditions that require long-term antibiotic use
Having immune system disorders that significantly weaken the body's defenses
Recent use of antibiotics within past 48 hours
Having prostate infection (prostatitis) or prostate abscess
Known or suspected bloodstream infection (bacteremia)
Having urinary tract obstruction that requires surgical intervention
History of kidney transplantation

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Verified sites

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Responsive
North Estonia Medical Centre Foundation
Tallin, Estonia
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland
Responsive
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

Tebipenem pivoxil hydrobromide (TBP-PI-HBr)
is an oral antibiotic medication being studied for treating complicated urinary tract infections and acute pyelonephritis (kidney infections). It is designed to be taken by mouth, which may allow patients to avoid or reduce the need for intravenous treatment.
Imipenem-cilastatin
is an established intravenous antibiotic combination used to treat various bacterial infections, including urinary tract infections. It is given through a vein (intravenously) and is being used as the comparison medication in this study. This combination contains two components: imipenem (which fights bacteria) and cilastatin (which helps the body maintain effective levels of imipenem).

What is already known about the treatment

Tebipenem pivoxil hydrobromide
An oral antibiotic medication that belongs to the carbapenem class of antibacterials, specifically developed for treating complicated urinary tract infections and acute pyelonephritis. This novel drug is designed to provide a convenient oral alternative to traditional intravenous carbapenem antibiotics, working by inhibiting bacterial cell wall synthesis at the molecular level. Currently undergoing Phase 3 clinical trials, it represents a potential breakthrough in treating serious urinary tract infections in adult patients who would otherwise require intravenous therapy.
Imipenem-cilastatin
An established intravenous antibiotic combination medication where imipenem is a broad-spectrum carbapenem antibiotic, and cilastatin prevents the breakdown of imipenem in the kidneys. This medication works by interfering with bacterial cell wall synthesis and is commonly used in hospital settings to treat serious infections, including complicated urinary tract infections and acute pyelonephritis. The combination has been well-documented in medical literature and serves as a standard treatment option for severe bacterial infections requiring hospitalization.

Investigated diseases

Complicated Urinary Tract Infection (cUTI)
A serious infection affecting any part of the urinary system that is made more complex by structural abnormalities, urinary obstruction, or other factors that make the infection harder to treat. The infection typically involves bacteria entering and multiplying in the urinary tract, causing symptoms like severe pain, fever, and changes in urinary habits. The condition often requires immediate medical attention due to the risk of the infection spreading to other parts of the urinary system.
Acute Pyelonephritis (AP)
A sudden and severe kidney infection that occurs when bacteria travel up from the bladder to one or both kidneys. The condition causes inflammation of the kidney tissue and can produce symptoms such as high fever, back or side pain, and frequent painful urination. Acute pyelonephritis typically develops rapidly and causes more intense symptoms than a simple urinary tract infection.