Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean Delivery

NCT05647993 | Completed DMC

• 1 other identifier: 65094
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section is the common surgery in world wide. But the complication like febrile morbidity such as surgical site infection, fever, urinary tract infection and endometritis can be occurred even giving the standard antibiotics. Therefore if wider bacterial spectrum coverage antibiotic like azithromycin is added to the standard antimicrobial prophylaxis(1st generation cephalosporin), the incidence of febrile morbidity could be reduced. We will compare the regimen of cefazolin plus azithromycin and standard regimen of cefazolin alone in prevention of febrile morbidity after emergency cesarean section.

Conditions

Febrile Morbidity After Emergency Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Incidence of febrile morbidity at postoperative day 3

  Patient will be assessed at postoperative day 3. Febrile morbidity is including surgical site infection, endometritis, urinary tract infection and fever. There is the questionnaire for the assessor to check if there is the febrile morbidity or not. (There are criteria diagnosis of febrile morbidity from the CDC in the questionnaire)

  postoperative day 3

Secondary Outcomes (3)

• adverse drug effect

  baseline and postoperative day 3, 7 and 30

• Incidence of adverse Neonatal outcome

  baseline and postoperative day 3, 7 and 30

• Incidence of febrile morbidity at postoperative day 7 and day 30

  postoperative day 7 and day 30

Study Arms (2)

Control group (Placebo)

PLACEBO COMPARATOR

Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision

Drug: Cefazolin; Drug: Sodium Chloride 0.9% Intravenous Solution

azithromycin

EXPERIMENTAL

Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision

Drug: Azithromycin Injection [Zithromax]; Drug: Cefazolin

Interventions

Azithromycin Injection [Zithromax] DRUG

Intervention group patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision

Also known as: azithromycin

azithromycin

Cefazolin DRUG

All the participants will receive the cefazolin intravenously. The dosage of the cefazolin is depend on participant's weight. The participant with weight less than 80kg will receive cefazolin 1 gm and between 80-120kg will receive cefazolin 2 gm and for the participant with more than 120kg will receive cefazolin 3 gm before the incision.

Also known as: azithromycin, placebo comparator

Control group (Placebo); azithromycin

Sodium Chloride 0.9% Intravenous Solution DRUG

For the placebo group will receive the cefazolin intravenously and 0.9% NaCl 100ml before the incision

Also known as: placebo comparator

Control group (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: for singleton pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy with a gestation of 24 weeks or more
• Undergoing non-elective cesarean delivery during labor or rupture of membrane more than 4 hr
• No allergy to macrolide such as azithromycin and clindamycin
• Provide informed consent
• Partner of participant allows the patient to participate the research

You may not qualify if:

• Use of azithromycin within 7 days before enrollment
• Chorioamnionitis or other infection requiring postpartum antibiotic therapy (except for antibiotics for group B streptococcus)
• Liver disease (Cirrhosis or AST more than 3 times the upper normal limit)
• Serum creatinine level of more than 2.0 mg/dL or need dialysis
• Diarrhea at the time of enrollment
• Maternal heart disease
• Use of medication known to prolonged the QT interval

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Azithromycin; Cefazolin; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 13, 2022
• Study Start: December 14, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 25, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)