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Pyelonephritis acute – Trials in Disease

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Ongoing Clinical Trials for Acute Pyelonephritis

This article provides information about 5 ongoing clinical trials focused on acute pyelonephritis, a serious kidney infection. These studies are investigating various antibiotic treatments, primarily in children and adults with complicated urinary tract infections. The trials are being conducted across multiple European countries and are testing both intravenous and oral antibiotic combinations to determine the most effective and safe treatment approaches.

Clinical trial locations

Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis

This study evaluates the safety and effectiveness of Vabomere, a combination medication containing meropenem and vaborbactam, in children between 3 months and 12 years of age who have complicated urinary tract infections or kidney infections.

Inclusion criteria: Children must be between 3 months and 12 years old. Those aged 3 months to 1 year must have been born after 37 weeks of pregnancy. The child must have a suspected or confirmed complicated urinary tract infection requiring at least 3 days of hospital treatment with intravenous antibiotics. Urine tests must show signs of infection, such as white blood cells. Children aged 2 or older need at least two symptoms like fever above 38°C, pain during urination, frequent urination, or pain in the lower belly or side. For children under 2 years, symptoms may include fever, poor growth, irritability, or vomiting. At least one complicating factor must be present, such as a urinary catheter, recent urinary surgery, or abnormal urinary tract structure.

Exclusion criteria: Children cannot participate if they are younger than 3 months or older than 12 years. Those with known allergies to Vabomere or similar antibiotics, severe kidney problems, or conditions that would interfere with study procedures are excluded. Pregnancy, breastfeeding, current use of other antibiotics that could affect results, severe infection requiring intensive care, and inability to comply with study visits are also exclusion factors.

Study focus: The main purpose is to examine how safe and well-tolerated Vabomere is in children with these infections. Participants will stay in the hospital initially and receive the medication through an intravenous infusion for at least 3 days. The total treatment period may last between 7 to 14 days. Doctors will monitor the children’s health by checking blood and urine samples, vital signs, and any side effects.

Investigational drug: Vabomere (meropenem-vaborbactam) is an intravenous antibiotic that combines meropenem, which kills bacteria, with vaborbactam, which helps prevent bacteria from becoming resistant to the antibiotic.

Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections

This trial studies how Vaborem, a combination of meropenem and vaborbactam, is absorbed and tolerated in children aged 3 months to less than 18 years with complicated urinary tract infections.

Inclusion criteria: Children must be between 3 months and less than 18 years old and require hospitalization for complicated urinary tract infection or kidney infection with at least 3 days of intravenous antibiotic treatment. A parent or legal representative must provide written consent, and the child must provide assent if age-appropriate. Participants must show evidence of white blood cells in the urine and have at least two symptoms appropriate to their age. A urine sample for culture must be collected within 48 hours before starting treatment.

Exclusion criteria: Participants who are not within the specified age range, do not have a complicated urinary tract infection, or are unable to receive multiple doses of the study medication through intravenous infusion cannot participate.

Study focus: The purpose is to understand how Vaborem is absorbed and processed in the body of children with these infections. The study will monitor how the medication affects the body, including measuring drug levels in the blood at different times. Researchers will track any changes in participants’ health, such as side effects or changes in laboratory test results.

Investigational drug: Vaborem is a combination of meropenem, an antibiotic that kills bacteria, and vaborbactam, which prevents certain bacteria from breaking down meropenem, making the treatment more effective.

Study on Antibiotic Treatments for Kidney Infection in Children: Comparing Cefixime, Ceftriaxone, and Amikacin for Ages 1 Month to 3 Years

This study compares two different treatment approaches for kidney infections in children aged 1 month to 3 years: a 3-day course of intravenous antibiotics alone versus the same 3-day intravenous treatment followed by 7 days of oral antibiotics.

Inclusion criteria: Children must be at least 1 month old and younger than 3 years old. For children younger than 3 months, they must have been born after 34 weeks of pregnancy. The child must be experiencing their first episode of a urinary tract infection with a fever of at least 38°C on the day of diagnosis and a positive urine test showing white blood cells. Initial treatment must include either ceftriaxone or amikacin antibiotics.

Exclusion criteria: Children who have a different type of kidney infection, are younger than 2 years old, have other serious health conditions, are allergic to the study antibiotics, have already been treated with antibiotics for this infection before joining the study, have a history of kidney problems unrelated to the current infection, are unable to take oral medication after initial treatment, or are participating in another clinical trial cannot participate.

Study focus: The purpose is to determine if a shorter intravenous-only treatment is as effective as longer treatment that includes oral antibiotics. The study will monitor the occurrence of kidney scarring, a potential complication of the infection, to see if there is any difference between the two treatment methods. Participants will be observed with follow-up checks to assess recovery and any potential side effects.

Investigational drugs: The study involves ceftriaxone and amikacin (given intravenously), as well as cefixime and sulfamethoxazole with trimethoprim (given orally). These antibiotics work by stopping bacteria from building their cell walls, leading to bacterial destruction.

Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis

This trial studies the treatment of complicated urinary tract infections, including kidney infections, using a combination of cefepime and enmetazobactam in participants from birth to 18 years of age who are hospitalized.

Inclusion criteria: Participants must be from birth to less than 18 years of age. If up to 2 months old, they must have been born at term or preterm with a gestational age of at least 32 weeks. They must have sufficient vein access to receive the study treatment. Written informed consent must be provided by parents or legal representatives, and the participant must provide assent if old enough. Female participants who have started menstruating must have a negative pregnancy test and agree to avoid pregnancy. Participants must have a suspected or confirmed complicated urinary tract infection requiring hospitalization for intravenous therapy, with the infection-causing bacteria treatable with the study medication. Urine must show signs of infection with white blood cells, and participants must show clinical signs such as fever, irritability, poor feeding, or abdominal pain.

Exclusion criteria: Patients with complicated urinary tract infections that include kidney infections cannot participate if they do not meet the inclusion criteria.

Study focus: The purpose is to understand how the body processes cefepime and enmetazobactam, as well as to assess their safety and how well they are tolerated. Participants will receive the medication through a two-hour intravenous infusion, and their health will be monitored closely to observe how their bodies respond to the treatment, including any side effects.

Investigational drug: Cefepime-Enmetazobactam is a combination medication where cefepime is an antibiotic that kills bacteria, and enmetazobactam enhances cefepime’s effect by preventing bacteria from breaking it down. The medication is given through an intravenous infusion.

Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis

This trial compares the effectiveness and safety of two treatment combinations—cefepime/nacubactam and aztreonam/nacubactam—against imipenem/cilastatin for adults with complicated urinary tract infections and kidney infections.

Inclusion criteria: Patients must be male or female and 18 years or older. They must weigh 140 kg (about 308 pounds) or less. The doctor must believe that the patient’s infection will need treatment with at least 5 days of intravenous antibiotics.

Exclusion criteria: Patients cannot participate if they have a history of severe allergic reactions to any of the study medications, known allergy to beta-lactam antibiotics (including penicillins and cephalosporins), history of liver disease or liver problems, kidney problems requiring dialysis, are pregnant or breastfeeding, have participated in another clinical trial within the last 30 days, have a history of drug or alcohol abuse, or have a condition that would make participation unsafe.

Study focus: The purpose is to evaluate how well these treatments work and how safe they are for patients with these infections. All medications are given through intravenous infusion. Participants will receive one of the treatment combinations, and their progress will be monitored over time with regular clinic visits for check-ups and assessments. The goal is to identify the best approach for managing these infections.

Investigational drugs: Cefepime/Nacubactam combines cefepime, an antibiotic that kills bacteria, with nacubactam, which enhances the antibiotic’s effectiveness by preventing bacteria from breaking it down. Aztreonam/Nacubactam combines aztreonam, an antibiotic that targets and kills bacteria, with nacubactam to boost effectiveness. Imipenem/Cilastatin is a standard treatment where imipenem fights bacteria and cilastatin prevents its breakdown in the kidneys.

Summary

These five clinical trials represent important research efforts to improve treatment options for kidney infections and complicated urinary tract infections, particularly in children. Four of the five studies focus on pediatric populations, reflecting a significant need for better understanding of antibiotic safety and effectiveness in younger patients.

The trials are spread across multiple European countries, with several studies taking place in Poland, Spain, France, and Czechia. This geographic distribution ensures diverse patient populations and robust data collection. A notable pattern is the focus on combination antibiotic therapies, where two medications work together to combat bacterial infections while preventing antibiotic resistance. Several studies are testing meropenem-vaborbactam combinations, while others explore cefepime-based combinations with different resistance inhibitors.

Most trials require hospitalization and intravenous antibiotic administration for at least 3 to 5 days, reflecting the serious nature of these infections. One unique study in France compares shorter intravenous treatment durations against combined intravenous and oral antibiotic approaches, which could potentially reduce hospital stays if proven effective.

The only adult-focused trial examines cefepime/nacubactam and aztreonam/nacubactam combinations in patients aged 18 and older across six countries in Central and Eastern Europe. This study represents an important effort to expand treatment options for adults with these challenging infections.

Ongoing Clinical Trials on Pyelonephritis acute

  • Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Italy Poland Spain

  • Study on 7-Day vs. 14-Day Antibiotic Treatment for Kidney Infection in Transplant Patients Using Bromhexine Hydrochloride, Trimethoprim, and Fluoroquinolones

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Hungary Poland Slovakia Spain

  • Study on Antibiotic Treatments for Kidney Infection in Children: Comparing Cefixime, Ceftriaxone, and Amikacin for Ages 1 Month to 3 Years

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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