| CTRI Number |
CTRI/2024/12/077949 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
Efficacy of adjuvent Azithromycin and 3rd generation cephalosporin to prevent post cessarean SSI: A randomized control non inferiority trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PURNIMA SAGAR |
| Designation |
Junior residant (Academic) |
| Affiliation |
AIIMS PATNA |
| Address |
OPD, Room no 256, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna
IPD, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna
Patna
BIHAR
801507
India |
| Phone |
7428646515 |
| Fax |
|
| Email |
purnima.sagar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SangamJha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
OPD, Room no 256, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna
OPD, Room no 256, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna
Patna
BIHAR
801507
India |
| Phone |
9827388001 |
| Fax |
|
| Email |
sangam.jha78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PURNIMA SAGAR |
| Designation |
ACADEMIC JUNIOR RESIDENT |
| Affiliation |
AIIMS PATNA |
| Address |
OPD, Room no 256, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna
IPD, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna
Patna
BIHAR
801507
India |
| Phone |
7428646515 |
| Fax |
|
| Email |
purnima.sagar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Purnima Sagar, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Patna, Bihar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Purnima Sagar |
All India Institute of Medical Sciences |
OPD, Room no 256, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Patna
Patna
BIHAR |
7428646515
purnima.sagar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O85||Puerperal sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ceftriaxone, Cefuroxime |
Drug regime: Injection Ceftriaxone 1g IV single shot in pre op followed by Tab Cefuroxime 500 mg 12th hourly for 5 days. |
| Intervention |
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 azithromycin will be given if blood loss exceeded 1500 ml.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Undergoing c-section
No History of allergy for ceftriaxone and azithromycin
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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-section |
7 days, 14 days, 30 days, 42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
7 days, 14 days, 30 days, 42 days |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study investigates the efficacy of combining ceftriaxone and azithromycin as a prophylactic regimen for preventing surgical site infections (SSIs) post-cesarean section compared to ceftriaxone and cefuroxime. Rising cesarean rates and associated SSIs highlight the need for improved preventive strategies. Ceftriaxone targets skin flora but has limitations against fastidious vaginal pathogens. Azithromycin complements it by covering organisms like *Ureaplasma* and *Mycoplasma*, associated with endometritis and UTIs. This randomized controlled trial aims to assess infection rates, severity, and neonatal outcomes. If successful, it will provide evidence for cost-effective, enhanced prophylaxis tailored to Indian women undergoing cesarean delivery.
This two-arm, open label randomized controlled trial will be conducted at AIIMS Patna OBGYN department from January 2025 to January 2026. The study population includes Indian pregnant women aged 18–45 years at ≥28 weeks gestation undergoing cesarean sections. Eligible participants must meet inclusion criteria (e.g., no allergy to ceftriaxone or azithromycin) and will be randomized into two groups using block randomization and SNOSE for blinding. Group 1 (Control): Ceftriaxone 1g IV preoperatively + Cefuroxime 500 mg orally for 5 days. Group 2 (Intervention): Ceftriaxone 1g IV + Azithromycin 500 mg IV preoperatively, with an additional azithromycin dose if blood loss exceeds 1500 ml. The sample size will include 178 participants (89 per group) based on a non-inferiority margin and previous studies. Consecutive sampling will ensure enrollment. Data will be analyzed using an intention-to-treat (ITT) approach, with blinding maintained for participants and outcome assessors. The study will evaluate the effectiveness of the intervention in reducing SSIs and related complications. The analysis will be done as per intention to treat.
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