| CTRI Number |
CTRI/2024/04/066006 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Bacterial infection |
|
Scientific Title of Study
|
Assessement of bacterial infection in liver disease: A prospective study in a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hasbiya |
| Designation |
PharmD |
| Affiliation |
Karavali college of pharmacy |
| Address |
Margadangadi house, kolavur post, muttur village ,magalore taluk
DepartmentofPharmacyPractice,KaravaliCollegeofPharmacy, Vamanjoor,Mangalore,Karnataka-575028 DakshinaKannada KARNATAKA 575028 India
Dakshina Kannada
KARNATAKA
574144
India |
| Phone |
7349766928 |
| Fax |
|
| Email |
hasbiya371@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya vc |
| Designation |
Assistant professor |
| Affiliation |
Karavali college of pharmacy |
| Address |
DepartmentofPharmacology,KaravaliCollegeofPharmacy, Vamanjoor,Mangalore,Karnataka-575028 DakshinaKannada KARNATAKA 575028 India
DepartmentofPharmacology,KaravaliCollegeofPharmacy, Vamanjoor,Mangalore,Karnataka-575028 DakshinaKannada KARNATAKA 575028 India
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
8494977901 |
| Fax |
|
| Email |
divyamada14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya vc |
| Designation |
Assistant professor |
| Affiliation |
Karavali college of pharmacy |
| Address |
DepartmentofPharmacology,KaravaliCollegeofPharmacy, Vamanjoor,Mangalore,Karnataka-575028 DakshinaKannada KARNATAKA 575028 India
DepartmentofPharmacology,KaravaliCollegeofPharmacy, Vamanjoor,Mangalore,Karnataka-575028 DakshinaKannada KARNATAKA 575028 India
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
8494977901 |
| Fax |
|
| Email |
divyamada14@gmail.com |
|
|
Source of Monetary or Material Support
|
| FatherMullerMedicalCollegeHospital,Mangalore,Karnataka,India,575002 |
|
|
Primary Sponsor
|
| Name |
Hasbiya |
| Address |
DepartmentofPharmacyPractice,KaravaliCollegeofPharmacy, Vamanjoor,Mangalore,Karnataka-575028 |
| 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 |
| Dr Divya |
Father Muller Medical College Hospital |
FatherMullerMedical CollegeHospital, kankanady, Mangalore-575002 DakshinaKannada KARNATAKA
Dakshina Kannada
KARNATAKA |
8494977901
divyamada14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, (2) ICD-10 Condition: K758||Other specified inflammatory liverdiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute liver failure, alcoholic fatty liver disease, non alcoholic fatty liver disease, alcoholic hepatitis, hepatic abscesses, hepatitis A, B, C, Cirrhosis, hepatic encephalopathy, cholestasis, liver cancer, cholangitis and infection associated with liver diseases like bacteremia, pneumonia, urinary tract infection, spontaneous bacterial peritonitis, endocarditis who are admitted to inpatient department. |
|
| ExclusionCriteria |
| Details |
Patients below the age group of 18 years, Patients who are unresponsive, unconscious and comatose ,Patients admitted due to psychiatric conditions, Patients who are not willing to participate in the study, Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study results will give an overview of the prevalence and specific bacterial strain associated with liver disease. The outcome will result in better diagnosis, treatment and management strategies. Identification of specific bacterial strain will help in the development of targeted antimicrobial agent, addressing the unique challenges posed by infections in liver disease patients. |
0 15 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will provide current treatment modalities and reporting of adverse drug reaction |
0 15 30 days |
|
|
Target Sample Size
|
Total Sample Size="137"
Sample Size from India="137"
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)
|
29/04/2024 |
| 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="0"
Months="6"
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
|
Bacterial infection is a frequent and severe complication of various liver diseases including acute liver disease, chronic liver disease, cirrhosis, hepatitis etc. The compromised immune function and changes in the gut microbic associated with liver diseases can contribute to an increases susceptibility to infection. In several studies carried out in cirrhosis have documented high prevalence of bacterial infection. Acute or chronic liver patients with factors like gastrointestinal bleeding, low ascitic protein, prior spontaneous bacterial peritonitis and low serum albumin are at heightened risk. About one third of patients hospitalized with cirrhosis have atleast one infection and two third of such infections are health care associated or nosocomial in origin. The diagnosis of liver cirrhosis was based on clinical, biochemical and pathological data. Our study conducted in a tertiary care hospital aims to investigate prevalence and incidence of specific bacterial infection. The primary objective is to investigate the prevalence and specific bacterial strain associated with liver disease. The secondary objective is to evaluate current antibiotic treatment modalities and monitoring the adverse drug reactions. Patients demographics, medical history, treatment details and lab reports will be recorded. The studies implications are will give an overview of the prevalence and specific bacterial strain associated with liver disease. The outcome will result in better diagnosis, treatment and management strategies. Identification of specific bacterial strain will help in the development of targeted antimicrobial agent, addressing the unique challenges posed by infections in liver disease patients. |