| CTRI Number |
CTRI/2022/12/048571 [Registered on: 28/12/2022] Trial Registered Prospectively |
| Last Modified On: |
27/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Adjunctive Azithromycin prophylaxis for cesarean delivery |
|
Scientific Title of Study
|
Azithromycin as an adjunct prophylactic drug for prevention of SSI in cesarean delivery -A Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yuktha khanna |
| Designation |
P.G OBG |
| Affiliation |
Jawaharlal Nehru Medical College and medical research centre |
| Address |
Department of obstetrics and gynaecology,Jawaharlal Nehru Medical College and medical research centre, belagavi -590010
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
yuktha.scorpio94@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita Dalal |
| Designation |
Professor and head of department of obstetrics and gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College and medical research centre |
| Address |
Department of obstetrics and gynaecology
Jawaharlal Nehru Medical College and medical research centre, belagavi -590010
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yuktha khanna |
| Designation |
P.G OBG |
| Affiliation |
Jawaharlal Nehru Medical College and medical research centre |
| Address |
Department of obstetrics and gynaecology,Jawaharlal Nehru Medical College and medical research centre, belagavi -590010
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
yuktha.scorpio94@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and medical research centre, belagavi, Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Yuktha Khanna |
| Address |
Jawaharlal Nehru Medical College and medical research centre belagavi 590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Yuktha khanna |
Jawaharlal Nehru Medical College and medical research centre |
Department of obstetrics and gynaecology, Jawaharlal Nehru Medical College and medical research centre
Belgaum
KARNATAKA |
9600809703
-
yuktha.scorpio94@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institute Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O860||Infection of obstetric surgical wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Azithromycin 500mg IV will be given slowly over a period of 15-30 minutes within 0-60 minutes prior to incision |
There will be 2 groups .Group A will receive the standard antibiotic prophylactic drug injection Xone 1G IV.
Group B will receive the standard antibiotic prophylactic drug Xone 1G intravenously along with injection Azithromycin 500mg intravenously.The drugs will be given within 60 minutes prior to incision .The drugs will be given as a STAT dose. The primary outcome of surgical site infection will be compared and studied between 2 groups. |
| Comparator Agent |
Injection Xone 1g IV will be given within 0-60 minutes prior to incision. |
There will be 2 groups .Group A will receive the standard antibiotic prophylactic drug injection Xone 1G IV.
Group B will receive the standard antibiotic prophylactic drug Xone 1G IV along with injection Azithromycin 500mg intravenously.The drugs will be given within 60 minutes prior to incision and as a STAT dose.The primary outcome of surgical site infection will be compared and studied between 2 groups. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with a singleton pregnancy at gestational age of 28 weeks or more who are to undergo Cesarean section. |
|
| ExclusionCriteria |
| Details |
1)patients who are not willing to give consent
2)patients with underlying liver disease, chorioamnionitis or any other infection.
3)Patients with known structural heart disease or arrthymias .
4)Patients taking any medications known to prolong the QT interval
5)use of antibiotics 7 days prior to randomisation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be 2 groups .Group A will receive the standard antibiotic prophylactic drug injection Xone 1G IV.
Group B will receive the standard antibiotic prophylactic drug Xone 1G IV along with injection Azithromycin 500mg IV.
PRIMARY OUTCOME-
The primary outcome of surgical site infection will be compared and studied between 2 groups until the period of discharge from hospital
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
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)
|
01/01/2023 |
| 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="0"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There will be 2 groups .Group A will receive the standard antibiotic prophylactic drug injection Xone 1G IV. Group B will receive the standard antibiotic prophylactic drug Xone 1G IV along with injection Azithromycin 500mg IV. The primary outcome of surgical site infection will be compared and studied between 2 groups.The women will be followed up until the day of discharge for any induration,redness and discharge at the surgical infection site |