Recruiting

Study of Pivmecillinam and Amoxicillin/Clavulanic Acid for Treating Urinary Tract Infections in Patients with Multidrug-Resistant Bacteria

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on finding effective treatments for urinary tract infections (UTIs) and bacteremia caused by bacteria known as extended spectrum beta-lactamases (ESBL)-producing Enterobacterales. These bacteria are resistant to many common antibiotics, making infections difficult to treat. The study will explore the use of different antibiotics to see if they can be effective alternatives to the usual treatments. The antibiotics being studied include Amoxicillin/Clavulanic acid, Ciprofloxacin, Sulfamethoxazole/Trimethoprim, Ertapenem, and Pivmecillinam.

The purpose of the study is to determine if these alternative antibiotics can safely and effectively treat febrile UTIs, which are UTIs accompanied by fever, caused by ESBL-producing bacteria. Participants in the study will initially receive intravenous antibiotics for a few days. Once their condition is stable, they will switch to oral antibiotics. The study will monitor the participants' health to ensure the infection is resolved and no further antibiotic treatment is needed.

Throughout the study, participants will be observed for any signs of the infection returning and for any side effects from the antibiotics. The study will also check if the bacteria are still present in urine or stool samples after treatment. The goal is to find a reliable oral antibiotic treatment that can be used instead of the more commonly used antibiotics, which may not be effective against these resistant bacteria. The study will help doctors understand which antibiotics can be safely used to treat these challenging infections.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, informed consent must be signed. This confirms understanding and agreement to participate in the study.
Step 2
Initial treatment
Initial treatment involves receiving intravenous antibiotics for 1 to 5 days. This is necessary for patients with a positive urine and/or blood culture for extended spectrum beta-lactamases-producing Enterobacterales (EPE).
Step 3
Transition to oral medication
After the initial intravenous treatment, the treating physician will determine if it is safe to switch to oral medication. This decision is based on the patient's condition and response to treatment.
Step 4
Oral medication regimen
The oral medication regimen includes the use of amoxicillin/clavulanic acid, ciprofloxacin, sulfamethoxazole/trimethoprim, ertapenem, and pivmecillinam hydrochloride. These medications are administered orally, except for ertapenem, which is given intravenously.
The specific dosage and frequency of each medication will be determined by the treating physician based on individual needs and response to treatment.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring will occur to assess the clinical response. This includes checking for the resolution of symptoms such as fever and painful urination.
A follow-up urine culture will be conducted 7 to 10 days after the antibiotic treatment has been discontinued to ensure no growth of EPE.
Step 6
Completion of trial
The trial is considered complete when there is no need for further antibiotic treatment, as determined by the treating physician. This is assessed by the absence of symptoms for more than 24 hours.

Who can join the trial?

8 criteria

Adult men and women who are 18 years or older.
Have a urine and/or blood test that is positive for ESBL-producing Enterobacterales (a type of bacteria).
Have started treatment with intravenous antibiotics (medicine given through a vein) for 1-5 days.
The doctor believes it is safe to switch from intravenous to oral antibiotics (medicine taken by mouth).
Had a fever (temperature of 38.0°C or higher) at least once at home or in the hospital.
Show signs of a urinary tract infection (UTI) at the emergency room, such as flank pain (pain in the side), dysuria (painful urination), a positive dipstick test (a simple urine test), or tenderness over the kidneys.
Have signed an informed consent form, agreeing to participate in the study.
The doctor considers it safe to stop intravenous treatment and start oral antibiotics.

Who cannot join the trial?

9 criteria

Patients with a known allergy to any of the study medications cannot participate.
Patients who are pregnant or breastfeeding are not eligible for the study.
Individuals with severe liver or kidney disease are excluded from the trial.
Patients who have participated in another clinical trial within the last 30 days cannot join this study.
Anyone with a history of severe allergic reactions to antibiotics should not participate.
Patients with a compromised immune system, meaning their body's defense against infections is weakened, are not eligible.
Individuals with a history of drug or alcohol abuse in the past year are excluded.
Patients who are unable to take oral medications, meaning they cannot swallow pills, cannot participate.
Anyone with a medical condition that the study doctors believe would make participation unsafe is not eligible.

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Verified sites

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Region Halland
Verified
Varberg, Sweden
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Skane Skanes Universitetssjukhus
Verified
Lund, Sweden

Trial locations

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Investigated drugs

Pivmecillinam
is an antibiotic used to treat urinary tract infections (UTIs). It works by stopping the growth of bacteria that cause infections. In this trial, it is being tested to see if it can be a safe option for treating UTIs caused by specific bacteria that are resistant to some other antibiotics.
Amoxicillin/Clavulanic acid
is a combination of two medications. Amoxicillin is an antibiotic that kills bacteria, and Clavulanic acid helps prevent bacteria from becoming resistant to Amoxicillin. This combination is used to treat various infections, including UTIs. In this trial, it is being used to see if it can effectively treat UTIs caused by certain resistant bacteria.

What is already known about the treatment

Pivmecillinam
Pivmecillinam is an oral medication used to treat urinary tract infections (UTIs) and bacteremia caused by specific bacteria known as ESBL-producing Enterobacterales. It is currently being studied in clinical trials to determine its effectiveness as a step-down oral therapy, which means it is used after initial treatment with other antibiotics. Pivmecillinam works by interfering with the bacteria's ability to build their cell walls, ultimately leading to their death. It belongs to a class of drugs called beta-lactam antibiotics, which are commonly used to treat bacterial infections.
Amoxicillin/Clavulanic acid
Amoxicillin/Clavulanic acid is an oral antibiotic combination used to treat infections like urinary tract infections (UTIs) caused by ESBL-producing Enterobacterales. This medication is being evaluated in clinical trials as a step-down oral therapy, meaning it is used after initial treatment with other antibiotics. Amoxicillin works by disrupting the formation of bacterial cell walls, while Clavulanic acid helps prevent bacteria from breaking down Amoxicillin, making the combination more effective. It is classified as a beta-lactam antibiotic, which is a group of drugs used to combat bacterial infections.

Investigated diseases

Urinary tract infection caused by extended spectrum beta-lactamases-producing Enterobacterales – This infection occurs when bacteria that produce enzymes called extended spectrum beta-lactamases (ESBL) invade the urinary tract. These enzymes make the bacteria resistant to many common antibiotics. The infection typically starts in the lower urinary tract, affecting the bladder and urethra, and can progress to the kidneys if untreated. Symptoms often include a strong, persistent urge to urinate, a burning sensation during urination, and cloudy or strong-smelling urine. In some cases, the infection can cause fever and back pain, indicating that it may have reached the kidneys. The condition requires careful management due to the antibiotic resistance of the bacteria involved.