Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527560
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women with Pyelonephritis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEFURO
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
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 womans 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 Students t-test will be performed while nominal data will be analyzed using the chi-square test
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 Students t-test will be performed while nominal data will be analyzed using the chi-square test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None