Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.

NCT03502356 | Unknown Phase 1 DMC

• 1 other identifier: 2377
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The good standard antibiotic prophylaxis pre elective C S is cefazolin and this study will approve addition of azithromycin to cefazolin will reduce post CS infections more than cefazolin only.

Conditions

Randomized Controll Trial

Outcome Measures

Primary Outcomes (1)

• endometritis

  Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C \[100.4°F\]), abdominal pain, uterine tenderness, or purulent drainage from the uterus

  6 weeks after surgery

Study Arms (2)

Control Group

ACTIVE COMPARATOR

This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.

Drug: Azithromycin

Study Group

NO INTERVENTION

This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)

Interventions

Azithromycin DRUG

In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.

Also known as: Cefazolin

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age of 37 0/7 weeks and greater
• Elective cesarean section
• Medicaly free pregnant women

You may not qualify if:

• a known allergy to azithromycin
• obstetric complications
• azithromycin use within 7 days before randomization
• chorioamnionitis or other infection requiring postpartum antibiotic therapy
• Pre-gestational diabetes

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams

Cairo, Elabasy, 23, Egypt

RECRUITING

MeSH Terms

Interventions

Azithromycin; Cefazolin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• mohamed 20 amar, md

  ain shams

  STUDY CHAIR

Central Study Contacts

mohamed 20 amar, md

CONTACT

01024706467; drmohamed145@gmil.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cario egypt

Model Details: Control Group: This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative. Study Group: This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 18, 2018
• Study Start: April 20, 2018
• Primary Completion: June 20, 2018
• Study Completion: August 20, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

EG (1)