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

NCT06527560 | Recruiting Phase 4

• 1 other identifier: 2024-0118
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pyelonephritis in Pregnancy

Keywords

pyelonephritis; pregnancy; cefuroxime

Outcome Measures

Primary Outcomes (2)

• Clinical improvement

  No fever, improvement of lower back pain

  3 days

• Negative urine culture

  No growth of pathogenic bacteria in the urine culture

  21 days

Study Arms (2)

Intravenous cefuroxime

ACTIVE COMPARATOR

Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours

Drug: Cefuroxime

Oral axetil cefuroxime

EXPERIMENTAL

Oral axetil cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours

Drug: Cefuroxime Axetil

Interventions

Cefuroxime DRUG

Intravenous cefuroxime 750 mg every 8 hours

Also known as: intravenous antibiotics + placebo Oral

Intravenous cefuroxime

Cefuroxime Axetil DRUG

Oral cefuroxime 500 mg every 12 hours

Also known as: oral antibiotics + placebo IV

Oral axetil cefuroxime

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 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)"

You may not qualify 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 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (8)

• Ansaldi Y, Martinez de Tejada Weber B. Urinary tract infections in pregnancy. Clin Microbiol Infect. 2023 Oct;29(10):1249-1253. doi: 10.1016/j.cmi.2022.08.015. Epub 2022 Aug 27.

  PMID: 36031053 BACKGROUND

• Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1.

  PMID: 7160191 BACKGROUND

• Faro S, Pastorek JG 2nd, Plauche WC, Korndorffer FA, Aldridge KE. Short-course parenteral antibiotic therapy for pyelonephritis in pregnancy. South Med J. 1984 Apr;77(4):455-7. doi: 10.1097/00007611-198404000-00011.

  PMID: 6710201 BACKGROUND

• Finn A, Straughn A, Meyer M, Chubb J. Effect of dose and food on the bioavailability of cefuroxime axetil. Biopharm Drug Dispos. 1987 Nov-Dec;8(6):519-26. doi: 10.1002/bdd.2510080604.

  PMID: 3427209 BACKGROUND

• Gilstrap LC 3rd, Cunningham FG, Whalley PJ. Acute pyelonephritis in pregnancy: an anterospective study. Obstet Gynecol. 1981 Apr;57(4):409-13.

  PMID: 7243084 BACKGROUND

• Gilstrap LC 3rd, Ramin SM. Urinary tract infections during pregnancy. Obstet Gynecol Clin North Am. 2001 Sep;28(3):581-91. doi: 10.1016/s0889-8545(05)70219-9.

  PMID: 11512502 BACKGROUND

• Powell N, Wade L, Iqbal-Elahi R, McDonald C, Philips R, Owens R, Amir A, Cho S, Nampa T, Lim D, Tai K, Jadav M. Potential impact of national recommendations to use short course antibiotic therapy on antibiotic use in the emergency department of a UK hospital: retrospective observational study. Eur J Hosp Pharm. 2022 Mar;29(2):72-78. doi: 10.1136/ejhpharm-2021-002756. Epub 2021 Nov 12.

  PMID: 34772731 BACKGROUND

• Millar LK, Wing DA, Paul RH, Grimes DA. Outpatient treatment of pyelonephritis in pregnancy: a randomized controlled trial. Obstet Gynecol. 1995 Oct;86(4 Pt 1):560-4. doi: 10.1016/0029-7844(95)00244-l.

  PMID: 7675380 BACKGROUND

MeSH Terms

Conditions

Pyelonephritis

Interventions

Cefuroxime; cefuroxime axetil; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ricardo F Savaris, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo F Savaris, PhD

CONTACT

+55 51 33596042; rsavaris@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients, care providers and investigators will not be aware of the treatment arm. Statistical analysis will be performed using pre-established criteria to access coded treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel, non-inferiority trial

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)