NCT06527560

Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare rates of cure in pregnant women with pyelonephritis. The main question aims to answer: Can we treat pyelonephritis in pregnancy with oral cefuroxime alone? Pregnant women with pyelonephritis treated with intravenous cefuroxime will be the comparator. Participants will be asked to accept participation in the study and will be randomly allocated to one of the two arms: * Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours * Oral cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours

Detailed description

Urinary tract infections are common during pregnancy and can lead to pyelonephritis, a condition associated with morbidity in both the fetus and the pregnant woman. At HCPA, intravenous cefuroxime has been used until the antibiogram results from the pregnant woman's urine culture are available. However, this treatment requires hospitalization, which is financially burdensome and can affect the well-being of the pregnant woman. Despite this, there are not enough studies to investigate the use of oral cefuroxime as an initial treatment. Objective: To compare the efficacy of cefuroxime administered orally versus intravenously in curing pyelonephritis during pregnancy, aiming to test the non-inferiority of the oral treatment. Method: A randomized, prospective, triple-blind, two-arm study will be conducted. Pregnant women with pyelonephritis who agree to participate in the study at the time of hospitalization will receive the treatment: I) cefuroxime axetil 750mg IV every 8 hours and a placebo capsule 500mg; or II) 500mg orally every 12 hours and IV saline solution. These patients will be followed until the outcome is determined. After 48 hours in good clinical condition, the patients will be discharged and will continue treatment with cefuroxime axetil 500mg orally every 12 hours for 14 days. To analyze the difference in means and proportions with confidence intervals, Student's t-test will be performed, while nominal data will be analyzed using the chi-square test.

Conditions

• Pyelonephritis in Pregnancy

Interventions

Type	Name	Description
DRUG	Cefuroxime	Intravenous cefuroxime 750 mg every 8 hours
DRUG	Cefuroxime Axetil	Oral cefuroxime 500 mg every 12 hours

Timeline

• Start date: 2024-09-09
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-07-30
• Last updated: 2024-09-19

Locations

1 site across 1 country: Brazil