Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-04 @ 4:55 AM
Study NCT ID:
NCT06527560
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011704', 'term': 'Pyelonephritis'}], 'ancestors': [{'id': 'D009395', 'term': 'Nephritis, Interstitial'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011702', 'term': 'Pyelitis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002444', 'term': 'Cefuroxime'}, {'id': 'C040738', 'term': 'cefuroxime axetil'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, parallel, non-inferiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': '3 days', 'description': 'No fever, improvement of lower back pain'}, {'measure': 'Negative urine culture', 'timeFrame': '21 days', 'description': 'No growth of pathogenic bacteria in the urine culture'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pyelonephritis', 'pregnancy', 'cefuroxime'], 'conditions': ['Pyelonephritis in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '36031053', 'type': 'BACKGROUND', 'citation': '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': '7160191', 'type': 'BACKGROUND', 'citation': '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': '6710201', 'type': 'BACKGROUND', 'citation': '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': '3427209', 'type': 'BACKGROUND', 'citation': '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': '7243084', 'type': 'BACKGROUND', 'citation': 'Gilstrap LC 3rd, Cunningham FG, Whalley PJ. Acute pyelonephritis in pregnancy: an anterospective study. Obstet Gynecol. 1981 Apr;57(4):409-13.'}, {'pmid': '11512502', 'type': 'BACKGROUND', 'citation': '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': '34772731', 'type': 'BACKGROUND', 'citation': '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': '7675380', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare rates of cure in pregnant women with pyelonephritis. The main question aims to answer:\n\nCan we treat pyelonephritis in pregnancy with oral cefuroxime alone?\n\nPregnant women with pyelonephritis treated with intravenous cefuroxime will be the comparator.\n\nParticipants will be asked to accept participation in the study and will be randomly allocated to one of the two arms:\n\n* Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours\n* Oral cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours', 'detailedDescription': "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.\n\nObjective: 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.\n\nMethod: 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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:\n* Presence of lower back pain associated with\n* Dysuria with leukocyturia, or hematuria or nitrite in the urine test with at least one of the criteria below:\n* Leukocytosis (\\> 14,000 leukocytes/mL)\n* Warm extremities, thready pulse, and tachycardia (HR \\> 110 bpm)\n* Cyanosis and/or pallor\n* Tachypnea (RR \\> 30 breaths/min)\n* Arterial hypotension (SBP \\< 90mmHg)\n* Positive costovertebral angle tenderness\n* Urine culture with colony growth\n* Hyperthermia (≥ 37.8°C)"\n\nExclusion Criteria:\n\n* Do not wish to participate in the project.\n* Used antimicrobials prior to hospitalization (3-day period).\n* those who are allergic to cefuroxime.\n* Have a urine culture antibiogram resistant to cefuroxime AND absence of clinical improvement (in this case, will be excluded as modified intention to treat).\n* Have a diagnosis other than pyelonephritis, for example, appendicitis.\n* those in septic shock, defined as:\n\n * 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:\n * Respiratory rate greater than or equal to 22 breaths per minute;\n * Altered level of consciousness (Glasgow Coma Scale score less than 15);\n * Systolic blood pressure less than or equal to 100 mmHg.'}, 'identificationModule': {'nctId': 'NCT06527560', 'acronym': 'CEFURO', 'briefTitle': 'Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis', 'orgStudyIdInfo': {'id': '2024-0118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous cefuroxime', 'description': 'Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours', 'interventionNames': ['Drug: Cefuroxime']}, {'type': 'EXPERIMENTAL', 'label': 'Oral axetil cefuroxime', 'description': 'Oral axetil cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours', 'interventionNames': ['Drug: Cefuroxime Axetil']}], 'interventions': [{'name': 'Cefuroxime', 'type': 'DRUG', 'otherNames': ['intravenous antibiotics + placebo Oral'], 'description': 'Intravenous cefuroxime 750 mg every 8 hours', 'armGroupLabels': ['Intravenous cefuroxime']}, {'name': 'Cefuroxime Axetil', 'type': 'DRUG', 'otherNames': ['oral antibiotics + placebo IV'], 'description': 'Oral cefuroxime 500 mg every 12 hours', 'armGroupLabels': ['Oral axetil cefuroxime']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'RICARDO F SAVARIS, MD,PHD', 'role': 'CONTACT', 'email': 'rsavaris@hcpa.edu.br', 'phone': '+555133596042'}], 'facility': 'HCPA', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Ricardo F Savaris, PhD', 'role': 'CONTACT', 'email': 'rsavaris@hcpa.edu.br', 'phone': '+55 51 33596042'}], 'overallOfficials': [{'name': 'Ricardo F Savaris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clinicas de Porto Alegre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We did not decide what will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}