| CTRI Number |
CTRI/2024/10/075570 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of oral azithromycin in high risk pregnant women to prevent premature births before 37 weeks |
|
Scientific Title of Study
|
Efficacy of oral azithromycin in pregnant women living-in low-income neighborhoods with high-risk of reproductive tract infections to
prevent preterm birth
|
| Trial Acronym |
PPAZI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bireshwar Sinha |
| Designation |
Scientist and Assistant Director |
| Affiliation |
Society for Applied Studies |
| Address |
45 Kalu Sarai, Ground Floor, Infectious Disease Department
New Delhi
DELHI
110016
India |
| Phone |
01146043751 |
| Fax |
01146043756 |
| Email |
bireshwar.sinha@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bireshwar Sinha |
| Designation |
Scientist and Assistant Director |
| Affiliation |
Society for Applied Studies |
| Address |
45 Kalu Sarai, Ground Floor, Infectious Disease Department
New Delhi
DELHI
110016
India |
| Phone |
01146043751 |
| Fax |
01146043756 |
| Email |
bireshwar.sinha@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bireshwar Sinha |
| Designation |
Scientist and Assistant Director |
| Affiliation |
Society for Applied Studies |
| Address |
45 Kalu Sarai, Ground Floor, Infectious Disease Department
New Delhi
DELHI
110016
India |
| Phone |
01146043751 |
| Fax |
01146043756 |
| Email |
bireshwar.sinha@sas.org.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
|
|
|
Primary Sponsor
|
| Name |
Society for Applied Studies |
| Address |
Society for Applied Studies, Ground floor, Infectious Disease Department, 45, Kalu Sarai, New Delhi, India, PIN: 110016 |
| Type of Sponsor |
Research institution |
|
|
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 Ratna Biswas |
Lady Hardinge Medical College |
Obstetrics and Gynecology Department, LHMC and Associated Hospitals
,New Delhi, Delhi 110055
New Delhi
DELHI |
9971372695
drratnabiswaspaul@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Centre for Health Research and Development Society for Applied Studies |
Approved |
| Institutional Ethics Committee, Lady Hardinge Medical College & Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women at high risk of Reproductive tract infections (RTI) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Azithromycin |
2 doses (1 gm per day for 2 consecutive days) during pregnancy at 20-24 weeks and 28-32 weeks |
| Comparator Agent |
Calcium |
2 doses (500 mg per day for 2 consecutive days) during pregnancy at 20-24 weeks and 28-32 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women more than 18 years of age
2. Less than or equal to 20 weeks gestation
3. living in low-middle income urban and periurban neighborhoods
4. At high risk of RTI with any of the following criteria
a. Hb less than 10.5 g per dL by a laboratory test
b. High CRP equal to or more than 10 mg per dl
c. MUAC less than 24 cm OR BMI less than 18.5 kg per meter square OR BMI more than or equal to 30 kg per meter square
d. History of of Diabetes or on anti-diabetic medications.
e. Recurrent History of RTI or vaginal discharge (2 or more times) in last 12 months or any history of RTI or vaginal discharge in the last 6 months
f. History of RTI or genital infection in the partner in last 12 months
g. Past History of abortion, still birth, preterm or low birth weight delivery |
|
| ExclusionCriteria |
| Details |
1. known history of heart disease
2. recent history of jaundice within last 3 months
3. severe illness leading to hospitalization in last 3 months
4. history of previous serious allergic reaction to drugs
5. H/O of antibiotic intake within last 4 weeks
6. ongoing episode of RTI (temporary exclusion)
7. h/o of cervical incompetency
8. not willing for institutional delivery in study hospital
9. those planning to go out of the study area within the next 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preterm birth |
At birth (0 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Small and vulnerable newborns, stillbirths |
At birth |
| PSBI or sepsis, Growth, Cumulative use of Antibiotic use, Antibiotic free days |
8 weeks of infant age |
| Vaginal tract colonization by pathogenic organism (sub-sample) |
32 weeks of gestation |
| Puerperal pyrexia or sepsis |
8 weeks post delivery |
| Antimicrobial resistance in indicator bacteria in maternal and infant stool (sub- sample) |
8 weeks post delivery |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="4"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bireshwar.sinha@sas.org.in].
- For how long will this data be available start date provided 31-07-2029 and end date provided 31-07-2032?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
India
is amongst the countries with the highest prevalence of preterm birth and
contributes to around one-fifth of all preterm births, globally. Infections of
the reproductive tract, colonisation of fetal membranes and associated maternal
inflammatory immune response is recognized as a major trigger in most cases of
preterm birth. The risk of reproductive tract infections (RTI) is higher in
women living in low-income neighborhoods with poor sanitary conditions and in
those with anemia, malnutrition, diabetes, or poor menstrual hygiene.
Azithromycin is a broad-spectrum macrolide antibiotic with anti-inflammatory
properties and is commonly used for symptomatic reproductive tract infections.
Previous evidence from African trials in malaria holoendemic settings suggest
that 2-dose azithromycin in the antenatal period can substantially reduce
preterm births. It is unclear whether the intervention works in South Asian
settings. Our primary study objective is to evaluate whether two doses of oral
azithromycin (2 g) during the antenatal period, after first trimester (20-24
weeks) and at 28-32 weeks of gestation in Indian women living-in low-income
neighborhoods with high-risk of reproductive tract infections can substantially
prevent preterm birth and birth of other small vulnerable infants. We will also
evaluate the two doses of azithromycin is associated with reduction of neonatal
sepsis, puerperal pyrexia, or sepsis in the mothers, need for antibiotic use
during the first 2 months of birth, any increase in the cumulative incidence of
phenotypic macrolide resistance in women and children |