Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis (NCT06527560) | Clinical Trial Compass
RecruitingPhase 4
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
Brazil100 participantsStarted 2024-09-09
Plain-language 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
Who can participate
Age range18 Years – 48 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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 co…