Actively Recruiting
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
Led by Hospital de Clinicas de Porto Alegre · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 years or older and less than 20 weeks of gestation
- Clinical diagnosis of pyelonephritis during pregnancy with symptoms such as lower back pain
- Dysuria with leukocyturia, hematuria, or nitrite in urine test plus at least one of leukocytosis (> 14,000 leukocytes/mL), warm extremities with thready pulse and tachycardia (HR > 110 bpm), cyanosis or pallor, tachypnea (RR > 30 breaths/min), low blood pressure (SBP < 90 mmHg), or positive costovertebral angle tenderness
- Positive urine culture with bacterial growth
- Fever of 37.8°C or higher
You will not qualify if you...
- Decline to participate in the study
- Use of antimicrobials within 3 days before hospitalization
- Allergy to cefuroxime
- Urine culture resistant to cefuroxime and no clinical improvement
- Diagnosis other than pyelonephritis, such as appendicitis
- Septic shock requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg and lactate > 2 mmol/l or positive qSOFA score (2 or more of respiratory rate ≥ 22, altered consciousness, systolic blood pressure ≤ 100 mmHg)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
HCPA
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
Research Team
R
Ricardo F Savaris, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here