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

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What is this study about?

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.

1 joining the trial

Upon joining the trial, informed consent must be signed. This confirms understanding and agreement to participate in the study.

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).

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Region Vaestmanland Vasteras Sweden

Other Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden
Region Skane Helsingborg Hospital Helsingborg Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen Kalmar Sweden
Region Jaemtland Haerjedalen Ostersund Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen Skovde Sweden
Region Norrbotten Lulea Sweden
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland Norrkoping Sweden
Region Vaesternorrland Sundsvall Sweden
NU Hospital Group-Vaestra Goetalandsregionen Trollhattan Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Region Skane Kristianstad Central Hospital Kristianstad Sweden
Sankt Gorans Sjukhus Stockholm Sweden
Malarsjukhuset Eskilstuna Eskilstuna Sweden
Region Halland Varberg Sweden
Rsbhjz Gcrpdjc Visby Sweden
Rqcamh Vmdqaspsl Karlstad Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
17.04.2023

Trial locations

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.

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.

Trial ID:
2024-513294-41-00
Protocol code:
TPLBIS20
NCT ID:
NCT05224401
Trial Phase:
Therapeutic confirmatory (Phase III)

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