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Comparing the efficacy of single dose Azithromycin vs multiple dose Cefuroxime in addition to Ceftriaxone to Prevent post-surgery infection in women undergoing cessarean section

Efficacy of adjuvent Azithromycin and 3rd generation cephalosporin to prevent post cessarean SSI: A randomized control non inferiority trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077949
Enrollment
178
Registered
2024-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O85- Puerperal sepsis

Interventions

Intervention1: group2: Drug regime: Injection Ceftriaxone 1gm IV once only + injection Azithromycin 500 mg IV in 250 ml of NS within 1 hour once only 30-60 minutes before incision. A repeat dose of a

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Undergoing c-section No History of allergy for ceftriaxone and azithromycin

Exclusion criteria

Exclusion criteria: Use of antibiotics in the last 7 days of c-section. Known allergy to any of the study antibiotics. Ruptured membranes for more than 24 h or at place other than the hospital Evidence of infection or fever, preoperatively or during surgery Women with any comorbidity, e.g., overt DM, TB, any heart disease, or any chronic illness. Preop hemoglobin less than 7g/dl

Design outcomes

Primary

MeasureTime frame
To compare the incidence of SSI between prophylactic combination of ceftriaxone and azithromycin and prophylactic combination ceftriaxone and cefuroxime in Indian pregnant women undergoing c-sectionTimepoint: 7 days, 14 days, 30 days, 42 days

Secondary

MeasureTime frame
1. To compare severity, time to develop surgical site infection between two groups. 2. To compare severity of SSI between 2 groups. 3. To compare the incidence of the neonatal sepsis between two groups. 4. To compare incidence, time to develop UTI between two groups. 5. To compare incidence, time to develop Endometritis between two groups. Timepoint: 7 days, 14 days, 30 days, 42 days

Countries

India

Contacts

Public ContactPURNIMA SAGAR

AIIMS PATNA

sangam.jha78@gmail.com9827388001

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026