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

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ClinicalTrials.gov Identifier: NCT05647993
Recruitment Status : Recruiting
First Posted : December 13, 2022
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : December 14, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of febrile morbidity at postoperative day 3 [ Time Frame: 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 :
  1. adverse drug effect [ Time Frame: baseline and postoperative day 3, 7 and 30 ]
    Any adverse drug effect of azithromycin such as diarrhea, urticaria, and anaphylactic shock

  2. Incidence of adverse Neonatal outcome [ Time Frame: 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)

  3. Incidence of febrile morbidity at postoperative day 7 and day 30 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   for singleton pregnant
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Use of azithromycin within 7 days before enrollment
  2. Chorioamnionitis or other infection requiring postpartum antibiotic therapy (except for antibiotics for group B streptococcus)
  3. Liver disease (Cirrhosis or AST more than 3 times the upper normal limit)
  4. Serum creatinine level of more than 2.0 mg/dL or need dialysis
  5. Diarrhea at the time of enrollment
  6. Maternal heart disease
  7. Use of medication known to prolonged the QT interval
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05647993


Contacts
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Contact: Riko Ogaki 0897622272 riko.ogaki@gmail.com
Contact: Putsarat Insin 0857163560 mamieo3020@gmail.com

Locations
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Thailand
Rajavithi Hospital Recruiting
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
More Information
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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT05647993    
Other Study ID Numbers: 65094
First Posted: December 13, 2022    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Hyperthermia
Fever
Disease Attributes
Pathologic Processes
Body Temperature Changes
 Heat Stress Disorders
Wounds and Injuries
Azithromycin
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents