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

Sponsor

Rajavithi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05647993

Collaborator

(none)

172

Enrollment

Arms

12.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Febrile Morbidity After Emergency Cesarean Section	Drug: Azithromycin Injection [Zithromax] Drug: Cefazolin Drug: Sodium Chloride 0.9% Intravenous Solution	N/A

Detailed Description

This study was designed to evaluate the effect of azithromycin on the incidence of febrile morbidity after the emergency cesarean section. The standard antimicrobial prophylaxis which is recommended by the ACOG is the 1st generation cephalosporin intravenously only but some of the bacteria that can cause the febrile morbidity after cesarean section wouldn't be killed by the 1st generation cephalosporin. The antibiotic that can cover them is macrolide group antibiotic such as azithromycin. Therefore this study will compare the regimen of standard antimicrobial prophylaxis and the regimen of standard antimicrobial prophylaxis with azithromycin intravenously in preventing the febrile morbidity after emergency cesarean section. Control group will receive the 1st generation cephalosporin intravenously and the intervention group will receive the 1st generation cephalosporin with azithromycin 500mg intravenously. Primary outcome is febrile morbidity which assessed at postoperative day 3. The definition of the febrile morbidity in this study is including surgical site infection, endometritis, urinary tract infection and fever alone. Secondary outcomes are febrile morbidity at postoperative day 7 and day30, neonatal outcome and adverse effect from azithromycin use.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparing of Cefazolin Plus Azithromycin Versus Cefazolin Alone in Prevention of Febrile Morbidity After Emergency Cesarean Delivery: A Randomized Controlled Trial

Anticipated Study Start Date :

Dec 14, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group (Placebo) Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision	Drug: Cefazolin 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. Other Names: azithromycin placebo comparator Drug: Sodium Chloride 0.9% Intravenous Solution For the placebo group will receive the cefazolin intravenously and 0.9% NaCl 100ml before the incision Other Names: placebo comparator
Experimental: azithromycin Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision	Drug: Azithromycin Injection [Zithromax] Intervention group patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision Other Names: azithromycin Drug: Cefazolin 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. Other Names: azithromycin placebo comparator

Arm

Intervention/Treatment

Placebo Comparator: Control group (Placebo)

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

Drug: Cefazolin

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.

Other Names:

azithromycin

placebo comparator

Drug: Sodium Chloride 0.9% Intravenous Solution

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

Other Names:

placebo comparator

Experimental: azithromycin

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

Drug: Azithromycin Injection [Zithromax]

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

Other Names:

azithromycin

Drug: Cefazolin

Other Names:

azithromycin

placebo comparator

Outcome Measures

Primary Outcome Measures

Incidence of febrile morbidity at postoperative day 3 [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)

Secondary Outcome Measures

adverse drug effect [baseline and postoperative day 3, 7 and 30]
Any adverse drug effect of azithromycin such as diarrhea, urticaria, and anaphylactic shock
Incidence of adverse Neonatal outcome [baseline and postoperative day 3, 7 and 30]
any adverse neonatal outcome such as NICU admission, neonatal sepsis, need phototherapy, respiratory distress, Apgar score, neonatal death and neonatal enterocolitis (Assessed and diagnosis by pediatric doctor)
Incidence of febrile morbidity at postoperative day 7 and day 30 [postoperative day 7 and day 30]
Patient will be assessed at postoperative day 7 and day 30. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rajavithi Hospital

ClinicalTrials.gov Identifier:

NCT05647993

Other Study ID Numbers:

65094

First Posted:

Dec 13, 2022

Last Update Posted:

Dec 13, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2022