| CTRI Number |
CTRI/2026/03/106292 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study comparing treatment outcomes and antibiotic resistance in hospitalized patients with different types of Acinetobacter baumannii infections |
|
Scientific Title of Study
|
To study the Clinical Profile, Antimicrobial Resistance Pattern, and Clinical
Outcomes in Patients with Hospital-Acquired Infections Caused by Biofilm-Producing and
Non-Biofilm-Producing Acinetobacter baumannii- A prospective cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubha Modi |
| Designation |
Junior resident, general medicine |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Medicine, Groud floor, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7037598749 |
| Fax |
|
| Email |
modi.shubha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Naveen Angadi |
| Designation |
Professor, general medicine |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Medicine, Ground floor, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880940984 |
| Fax |
|
| Email |
naveenangadi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubha Modi |
| Designation |
Junior resident, general medicine |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Medicine, ground floor, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
7037598749 |
| Fax |
|
| Email |
modi.shubha123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shubha Modi |
| Address |
Department of medicine, Jawaharlal Nehru medical college, Belagavi, Karnataka- 590010 |
| Type of Sponsor |
Other [Myself ] |
|
|
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 Shubha Modi |
Department of General Medicine, Jawaharlal Nehru Medical College, Belagavi |
Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
7037598749
modi.shubha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with hospital-acquired infections caused by Acinetobacter baumannii, confirmed by microbiological culture, in patients of age above 18 years, showing clinical signs of infection correlated with Acinetobacter baumannii infection isolated, admitted in medical or surgical wards or ICU, with availability of sufficient data including comorbidities, treatment, length of hospital stay history and outcome, after obtaining written consent as per requirement of ethics guidelines. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Biofilm forming Acinetobacter baumannii infection is more resistant compared to non biofilm forming organism |
7 days and 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/04/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Gaining insights into how biofilm-producing and non-biofilm-producing A. baumannii strains differ in terms of clinical symptoms, resistance profiles, and patient outcomes is essential for developing effective treatment plans and improving infection control practices |