Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial

What this Trial Is About

Kidney transplant recipients often face serious infections, with urinary tract infections (UTIs) being particularly common and dangerous. These infections, frequently caused by E. coli and other gram-negative bacteria, can lead to acute pyelonephritis and increase the risk of kidney rejection and long-term graft problems. Because of frequent antibiotic use and immunosuppression, these patients are at high risk for infections resistant to multiple antibiotics. This trial investigates whether a shorter 7-day antibiotic treatment is as effective as the usual 14-day course for treating acute pyelonephritis in this group. Participants will be randomly assigned to receive either a 7-day or a 14-day course of antibiotics, with the specific antibiotic chosen by their medical team. The study is a phase 3, single-masked, multicenter trial comparing these two treatment durations to see if the shorter treatment is not less effective than the longer one. Patients must show early improvement after about 48 to 60 hours of antibiotic therapy to be eligible. During the trial, patients will be monitored for clinical cure at 30 days, with additional assessments at 90 and 180 days for clinical and microbiological cure, kidney function, relapse rates, antibiotic use, hospital stay length, and adverse events. Researchers will also check for resistant bacteria carriage at the start and after 30 days. The total follow-up period extends up to six months, allowing thorough evaluation of treatment outcomes and safety.

Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial.