Comparing oral and intravenous cefuroxime for treating pyelonephritis in pregnant women

Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis

This study is testing whether taking cefuroxime by mouth is just as effective as getting it through an IV for treating kidney infections in pregnant women.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 48 Years
• Sex: Female
• Sponsor: Hospital de Clinicas de Porto Alegre (Academic / other)
• Locations: 1 site (Porto Alegre, Rio Grande do Sul)
• Trial ID: NCT06527560 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18 years or older, less than 20 weeks of gestation, who have been diagnosed with pyelonephritis.

Not a fit: Patients who have used antimicrobials prior to hospitalization or have an allergy to cefuroxime may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive and more cost-effective treatment option for pregnant women suffering from pyelonephritis.

How similar studies have performed: While there is limited research on the use of oral cefuroxime for this condition, the study aims to fill a gap in existing literature regarding treatment options for pyelonephritis in pregnancy.

Eligibility criteria

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 this trial is running

Porto Alegre, Rio Grande do Sul

• 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

Conditions Pyelonephritis in Pregnancy; pyelonephritis; pregnancy; cefuroxime