Status:
RECRUITING
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Pyelonephritis in Pregnancy
Eligibility:
FEMALE
18-48 years
Phase:
PHASE4
Brief 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 alon...
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...
Eligibility Criteria
Inclusion
- Pregnant women aged 18 years or older and less than 20 weeks of gestational age, determined by ultrasound or the date of last menstruation, who come to the HCPA emergency department with a clinical diagnosis of pyelonephritis in pregnancy, defined as:
- Presence of lower back pain associated with
- Dysuria with leukocyturia, or hematuria or nitrite in the urine test with at least one of the criteria below:
- Leukocytosis (\> 14,000 leukocytes/mL)
- Warm extremities, thready pulse, and tachycardia (HR \> 110 bpm)
- Cyanosis and/or pallor
- Tachypnea (RR \> 30 breaths/min)
- Arterial hypotension (SBP \< 90mmHg)
- Positive costovertebral angle tenderness
- Urine culture with colony growth
- Hyperthermia (≥ 37.8°C)"
Exclusion
- Do not wish to participate in the project.
- Used antimicrobials prior to hospitalization (3-day period).
- those who are allergic to cefuroxime.
- Have a urine culture antibiogram resistant to cefuroxime AND absence of clinical improvement (in this case, will be excluded as modified intention to treat).
- Have a diagnosis other than pyelonephritis, for example, appendicitis.
- those in septic shock, defined as:
- the need for vasopressor to maintain a mean arterial pressure ≥ 65 mmHg and lactate \> 2 mmol/l or 2 points on qSOFA. qSOFA will be considered positive when at least two of the following clinical criteria are present:
- Respiratory rate greater than or equal to 22 breaths per minute;
- Altered level of consciousness (Glasgow Coma Scale score less than 15);
- Systolic blood pressure less than or equal to 100 mmHg.
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06527560
Start Date
September 9 2024
End Date
December 31 2027
Last Update
September 19 2024
Active Locations (1)
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1
HCPA
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903