Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605118
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
Status:
NOT_YET_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:
PRECEDE
Brief Summary:
This is a phase-III multi-center double-blind randomized controlled trial of 8000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo Both groups also will receive standard of care preoperative antibiotics excluding azithromycin The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum endometritis wound infection abscess septic thrombosis sepsis pneumonia pyelonephritis and breast infection
Detailed Description:
This is a phase-III multi-center double-blind randomized controlled trial of 8000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either azithromycin prophylaxis or to placebo All participants will receive standard of care preoperative antibiotics The primary objective is to evaluate in patients undergoing scheduledprelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo Secondary objectives include 1 to assess the perinatal and maternal safety of pre-incision adjunctive azithromycin 2 to evaluate whether adjunctive azithromycin prophylaxis reduces maternal and neonatal resource use outcomes compared with placebo and 3 to evaluate whether adjunctive azithromycin influences maternal and neonatal infection with resistant organisms compared with placebo
Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo normal saline Maternal blood and cord blood will be collected on a subset of the population Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital A single maternal follow-up study visit at 6 weeks 4-8 weeks postpartum will be scheduled to ascertain maternal and neonatal outcomes
Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo normal saline Maternal blood and cord blood will be collected on a subset of the population Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital A single maternal follow-up study visit at 6 weeks 4-8 weeks postpartum will be scheduled to ascertain maternal and neonatal outcomes
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