Comparing oral and intravenous cefuroxime for treating pyelonephritis in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of oral cefuroxime versus intravenous cefuroxime in treating pyelonephritis in pregnant women. Participants will be randomly assigned to receive either intravenous cefuroxime or oral cefuroxime, with the goal of determining if the oral treatment is as effective as the intravenous option. The study will follow participants until the treatment outcome is assessed, focusing on the rates of cure and overall health of both the mother and fetus. The trial is designed to be triple-blind to ensure unbiased results.

Why it matters

Who can join: the full rules

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 consciousness (Glasgow Coma Scale score less than 15);
  * Systolic blood pressure less than or equal to 100 mmHg.

Where it's running

• Hcpa
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting

Study contacts

• Principal investigator: Ricardo F Savaris, PhD — Hospital de Clinicas de Porto Alegre
• Study coordinator: Ricardo F Savaris, PhD
• Email: rsavaris@hcpa.edu.br
• Phone: +55 51 33596042

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.