Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women With Pyelonephritis (CEFURO)

July 25, 2024 updated by: Hospital de Clinicas de Porto Alegre

Ensaio clínico Entre Cefuroxima Por Via Oral ou Por Via Intravenosa em Gestantes Com Pielonefrite

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 been used until the antibiogram results from the pregnant woman's urine culture are available. However, this treatment requires hospitalization, which is financially burdensome and can affect the well-being of the pregnant woman. Despite this, there are not enough studies to investigate the use of oral cefuroxime as an initial treatment.

Objective: To compare the efficacy of cefuroxime administered orally versus intravenously in curing pyelonephritis during pregnancy, aiming to test the non-inferiority of the oral treatment.

Method: A randomized, prospective, triple-blind, two-arm study will be conducted. Pregnant women with pyelonephritis who agree to participate in the study at the time of hospitalization will receive the treatment: I) cefuroxime axetil 750mg IV every 8 hours and a placebo capsule 500mg; or II) 500mg orally every 12 hours and IV saline solution. These patients will be followed until the outcome is determined. After 48 hours in good clinical condition, the patients will be discharged and will continue treatment with cefuroxime axetil 500mg orally every 12 hours for 14 days. To analyze the difference in means and proportions with confidence intervals, Student's t-test will be performed, while nominal data will be analyzed using the chi-square test.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous
Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours
Drug: Cefuroxime
Intravenous cefuroxime 750 mg every 8 hours
Experimental: Oral
Oral cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours
Drug: Cefuroxime Axetil
Oral cefuroxime 500 mg every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 3 days
No fever, improvement of lower back pain
3 days
Negative urine culture
Time Frame: 21 days
No growth of pathogenic bacteria in the urine culture
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo F Savaris, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We did not decide what will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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