Pyelonephritis in PregnancyPhase 4CEFURONCT06527560
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
A Phase 4 study testing Cefuroxime and Cefuroxime Axetil in people with Pyelonephritis in Pregnancy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Pyelonephritis in Pregnancy
- What is being tested?
- Cefuroxime and Cefuroxime Axetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Sep 2024to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- Tachypnea (RR > 30 breaths/min)
- Arterial hypotension (SBP < 90mmHg)
- Positive costovertebral angle tenderness
- Urine culture with colony growth
- Hyperthermia (≥ 37.8°C)"
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
HCPA
Porto Alegre, Rio Grande do Sul, 90035-903
RICARDO F SAVARIS, MD,PHD, +555133596042, rsavaris@hcpa.edu.br
About this study
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
Read the 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.
- Conditions
- Pyelonephritis in Pregnancy
- Being tested
- Cefuroxime, Cefuroxime Axetil
- Keywords
- pyelonephritis, pregnancy, cefuroxime
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
Also called intravenous antibiotics + placebo Oral
Intravenous cefuroxime 750 mg every 8 hours
Cefuroxime AxetilDrug
Also called oral antibiotics + placebo IV
Oral cefuroxime 500 mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Intravenous cefuroxime | Active comparator | Intravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours Receives: Drug: Cefuroxime |
| Oral axetil cefuroxime | Experimental | Oral axetil cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours Receives: Drug: Cefuroxime Axetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
No fever, improvement of lower back pain
Measured: 3 days
Negative urine culture
No growth of pathogenic bacteria in the urine culture
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start9 Sep 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pyelonephritis in PregnancyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, non-inferiority trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo F Savaris, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527560
- Sponsor's protocol ID
- 2024-0118
- Acronym
- CEFURO
- Status last verified
- Sep 2024
- First submitted
- 25 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We did not decide what will be shared
Publications
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.
PubMed 36031053Blackwelder 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.
PubMed 7160191Faro 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.
PubMed 6710201Finn 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.
PubMed 3427209Gilstrap LC 3rd, Cunningham FG, Whalley PJ. Acute pyelonephritis in pregnancy: an anterospective study. Obstet Gynecol. 1981 Apr;57(4):409-13.
PubMed 7243084Gilstrap 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.
PubMed 11512502Powell 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.
PubMed 34772731Millar 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.
PubMed 7675380
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
- ClinicalTrials.gov ID
- NCT06527560
- Acronym / sponsor ID
- CEFURO / 2024-0118
- Conditions
- Pyelonephritis in Pregnancy
- Keywords
- pyelonephritis, pregnancy, cefuroxime
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 9 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, parallel, non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Intravenous cefuroxime | Active comparator | Drug: CefuroximeIntravenous cefuroxime 750 mg every 8 hours + oral placebo every 12 hours |
| Oral axetil cefuroxime | Experimental | Drug: Cefuroxime AxetilOral axetil cefuroxime 500 mg every 12 hours + intravenous saline solution every 8 hours |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefuroximeAlso: intravenous antibiotics + placebo OralIntravenous cefuroxime 750 mg every 8 hours | Drug | Intravenous cefuroxime |
| Cefuroxime AxetilAlso: oral antibiotics + placebo IVOral cefuroxime 500 mg every 12 hours | Drug | Oral axetil cefuroxime |
Primary outcome
Clinical improvement
Time frame: 3 days
No fever, improvement of lower back pain
Negative urine culture
Time frame: 21 days
No growth of pathogenic bacteria in the urine culture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 36031053Ansaldi 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.
- Background: PubMed 7160191Blackwelder 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.
- Background: PubMed 6710201Faro 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.
- Background: PubMed 3427209Finn 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.
- Background: PubMed 7243084Gilstrap LC 3rd, Cunningham FG, Whalley PJ. Acute pyelonephritis in pregnancy: an anterospective study. Obstet Gynecol. 1981 Apr;57(4):409-13.
- Background: PubMed 11512502Gilstrap 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.
- Background: PubMed 34772731Powell 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.
- Background: PubMed 7675380Millar 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.
- Individual participant dataSharing planned: No. We did not decide what will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo F Savaris, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefuroxime and Cefuroxime Axetil in people with Pyelonephritis in Pregnancy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo F Savaris, PhD (+55 51 33596042, rsavaris@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527560, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.