Ongoing Clinical Trials for Pyelonephritis
There are currently 2 ongoing clinical trials investigating new approaches to treating pyelonephritis, a serious kidney infection. These trials are evaluating different antibiotic treatment strategies and durations, particularly in patients with kidney transplants and those with drug-resistant bacterial infections. The studies are taking place across several European countries including France, Slovakia, Czechia, Latvia, Croatia, Spain, and Greece.
Clinical trial locations
- Croatia
- Czechia
- France
- Greece
- Latvia
- Slovakia
- Spain
Study on 7-Day vs. 14-Day Antibiotic Treatment for Kidney Infection in Transplant Patients Using Bromhexine Hydrochloride, Trimethoprim, and Fluoroquinolones
This trial focuses on people who have received a kidney transplant and developed acute pyelonephritis. The main goal is to compare whether a shorter 7-day course of antibiotics works just as well as the standard 14-day treatment for kidney infections in transplant recipients.
Who can participate: You may be eligible if you are over 18 years old, have received a kidney transplant, and have been diagnosed with acute pyelonephritis. The diagnosis is confirmed by having a fever of 38°C or higher, white blood cells in the urine, and a positive urine culture showing bacteria that can be treated with the study antibiotics. You must also show improvement within the first 48 to 60 hours of starting antibiotics, with your fever dropping below 38°C and symptoms improving. Additionally, you cannot have other bacterial infections unrelated to the urinary system or any complications like abscesses or blockages in the urinary tract.
Who cannot participate: The trial excludes individuals who have had a kidney transplant specifically for this study, though this appears to be an error in the source data as the inclusion criteria specifically targets transplant recipients.
Treatment approach: Participants will receive oral antibiotics, specifically a combination of sulfamethoxazole and trimethoprim. Some participants will take the medication for 7 days, while others will take it for 14 days. The study will monitor participants at 30, 90, and 180 days after treatment ends to check for complete recovery, any return of the infection, and kidney function.
Investigational drugs: The trial uses standard antibiotic therapy including beta-lactam antibacterials, sulfamethoxazole with trimethoprim, and fluoroquinolones. These antibiotics work by killing bacteria or stopping them from growing, typically by interfering with bacterial cell walls or protein production.
Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
This trial examines new treatment options for serious infections caused by carbapenem-resistant bacteria, which are difficult to treat because they resist many common antibiotics. The study includes patients with acute uncomplicated pyelonephritis, along with other serious infections like complicated urinary tract infections, hospital-acquired pneumonia, and intra-abdominal infections.
Who can participate: You may be eligible if you are at least 18 years old, weigh 140 kg or less, and can stay in the hospital during treatment. You must have a confirmed or suspected infection with carbapenem-resistant Enterobacterales bacteria. If you have a confirmed infection, you should either have received no more than 24 hours of effective antibiotic treatment before joining the study, or you should have been on treatment for at least 48 hours without improvement. For suspected infections, similar timing requirements apply based on your test results or medical history from the past 90 days.
Who cannot participate: You cannot join if you have allergies to the study medications or similar antibiotics like penicillins or cephalosporins. The trial also excludes people with severe kidney problems requiring dialysis, significant liver disease, pregnant or breastfeeding women, those participating in other clinical trials, individuals with drug or alcohol abuse issues that might interfere with the study, people with weakened immune systems, and those who have taken certain antibiotics too recently before the study starts.
Treatment approach: The trial compares two antibiotic combinations given through intravenous infusion: cefepime/nacubactam and aztreonam/nacubactam. These will be compared against the best available standard therapy. Treatment can last up to 14 days, with close monitoring of your response and any side effects. The main measure of success is overall treatment effectiveness across all infection types at the end of the treatment period.
Investigational drugs: Cefepime/nacubactam combines cefepime, an antibiotic that kills bacteria, with nacubactam, which helps cefepime work better by blocking enzymes that bacteria use to resist antibiotics. Aztreonam/nacubactam works similarly, pairing aztreonam with nacubactam to overcome bacterial resistance. Both combinations are designed to fight bacteria that have become resistant to other antibiotics, particularly carbapenem-resistant bacteria.
Summary
These two ongoing clinical trials represent important research into improving treatment for pyelonephritis in different patient populations. The first study addresses a specific need for kidney transplant recipients, questioning whether shorter antibiotic courses could be equally effective while potentially reducing side effects and costs. The second trial tackles the growing challenge of antibiotic-resistant infections, testing new drug combinations that may offer hope for patients with hard-to-treat bacterial strains.
The trials are concentrated in European countries, with France participating in both studies. The second trial has broader geographic coverage across seven countries, reflecting the international concern about antibiotic resistance. Both studies emphasize careful patient monitoring and safety, with follow-up periods extending several months after treatment to ensure lasting effectiveness.
These trials highlight two key areas of current research: optimizing treatment duration for vulnerable populations like transplant recipients, and developing new weapons against increasingly resistant bacteria. The results from these studies may influence future treatment guidelines and help physicians better manage kidney infections in these challenging scenarios.
