A Phase 4 interventional study of Cefuroxime and Cefuroxime Axetil in Pyelonephritis in Pregnancy, sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 4, Interventional, and Treatment
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:
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.
79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.
This study's planned enrollment of 100 is below the median of 175 across 62 interventional studies indexed under Pyelonephritis.
Browse Pyelonephritis studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
those in septic shock, defined as:
Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours
Drug: Cefuroxime
Oral axetil cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours
Drug: Cefuroxime Axetil
Intravenous cefuroxime 750 mg every 8 hours
Also known as: intravenous antibiotics + placebo Oral
Oral cefuroxime 500 mg every 12 hours
Also known as: oral antibiotics + placebo IV
Clinical improvement
No fever, improvement of lower back pain
Time frame: 3 days
Negative urine culture
No growth of pathogenic bacteria in the urine culture
Time frame: 21 days
Plan to share: No — We did not decide what will be shared
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Studies of the drug tested here: Cefuroxime axetil
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