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Compares treatment options for Pyelonephritis in Pregnancy
Official title Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
ClinicalTrials.gov ID: NCT06527560
What this study is testing
What is Cefuroxime?
Cefuroxime is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pyelonephritis in pregnancy.
Also referred to as intravenous antibiotics + placebo Oral.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 48, women only
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
- Have a diagnosis other than pyelonephritis, for example, appendicitis.
- those in septic shock, defined as:
See the full eligibility 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...
- 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)"
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 48 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.