| CTRI Number |
CTRI/2023/08/056619 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing antibiotic therapy in ICU patients with infections |
|
Scientific Title of Study
|
Empirical antibiotic prescription pattern in community acquired infections among critically ill patients in a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hari Naveen Ashok Kumar |
| Designation |
Academic Registrar |
| Affiliation |
Apollo Hospitals, Chennai |
| Address |
Department of Critical care medicine (2nd floor), Apollo Hospitals, 21, Greams lane, Greams road, Thousand lights, Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
9940537733 |
| Fax |
|
| Email |
harinaveen19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Dedeepiya Devaprasad |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals, Chennai |
| Address |
Department of Critical care medicine (2nd floor), Apollo Hospitals, 21, Greams lane, Greams road, Thousand lights, Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
9444216333 |
| Fax |
|
| Email |
dedeepiya_76@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hari Naveen Ashok Kumar |
| Designation |
Academic Registrar |
| Affiliation |
Apollo Hospitals, Chennai |
| Address |
Department of Critical care medicine (2nd floor), Apollo Hospitals, 21, Greams lane, Greams road, Thousand lights, Chennai
TAMIL NADU
600006
India |
| Phone |
9940537733 |
| Fax |
|
| Email |
harinaveen19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals, 21, greams lane, greams road, Thousand lights, Chennai - 600006 |
|
|
Primary Sponsor
|
| Name |
Hari Naveen Ashok Kumar |
| Address |
Apollo Hospitals,
21, Greams lane, Greams road, Thousand lights, Chennai - 600006 |
| 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 Hari Naveen Ashok Kumar |
Apollo Hospital |
Department of critical care medicine (2nd floor), 21, Greams lane, Greams road, Thousand lights
Chennai
TAMIL NADU |
9940537733
harinaveen19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Bio Medical Research, Apollo Hospitals, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B950||Streptococcus, group A, as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B951||Streptococcus, group B, as the cause of diseases classified elsewhere, (3) ICD-10 Condition: B952||Enterococcus as the cause of diseases classified elsewhere, (4) ICD-10 Condition: B953||Streptococcus pneumoniae as the cause of diseases classified elsewhere, (5) ICD-10 Condition: B954||Other streptococcus as the cause of diseases classified elsewhere, (6) ICD-10 Condition: B955||Unspecified streptococcus as the cause of diseases classified elsewhere, (7) ICD-10 Condition: B956||Staphylococcus aureus as the causeof diseases classified elsewhere, (8) ICD-10 Condition: B957||Other staphylococcus as the causeof diseases classified elsewhere, (9) ICD-10 Condition: B958||Unspecified staphylococcus as thecause of diseases classified elsewhere, (10) ICD-10 Condition: B960||Mycoplasma pneumoniae [M. pneumoniae] as the cause of diseases classified elsewhere, (11) ICD-10 Condition: B961||Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere, (12) ICD-10 Condition: B962||Escherichia coli [E. coli ] as thecause of diseases classified elsewhere, (13) ICD-10 Condition: B963||Hemophilus influenzae [H. influenzae] as the cause of diseases classified elsewhere, (14) ICD-10 Condition: B964||Proteus (mirabilis) (morganii) asthe cause of diseases classified elsewhere, (15) ICD-10 Condition: B966||Bacteroides fragilis [B. fragilis]as the cause of diseases classified elsewhere, (16) ICD-10 Condition: B967||Clostridium perfringens [C. perfringens] as the cause of diseases classified elsewhere, (17) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (18) ICD-10 Condition: A157||Primary respiratory tuberculosis, (19) ICD-10 Condition: A158||Other respiratory tuberculosis, (20) ICD-10 Condition: A159||Respiratory tuberculosis unspecified, (21) ICD-10 Condition: A170||Tuberculous meningitis, (22) ICD-10 Condition: A178||Other tuberculosis of nervous system, (23) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified, (24) ICD-10 Condition: A180||Tuberculosis of bones and joints, (25) ICD-10 Condition: A181||Tuberculosis of genitourinary system, (26) ICD-10 Condition: A182||Tuberculous peripheral lymphadenopathy, (27) ICD-10 Condition: A183||Tuberculosis of intestines, peritoneum and mesenteric glands, (28) ICD-10 Condition: A188||Tuberculosis of other specified organs, (29) ICD-10 Condition: A190||Acute miliary tuberculosis of a single specified site, (30) ICD-10 Condition: A191||Acute miliary tuberculosis of multiple sites, (31) ICD-10 Condition: A198||Other miliary tuberculosis, (32) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified, (33) ICD-10 Condition: A010||Typhoid fever, (34) ICD-10 Condition: A020||Salmonella enteritis, (35) ICD-10 Condition: A021||Salmonella sepsis, (36) ICD-10 Condition: A390||Meningococcal meningitis, (37) ICD-10 Condition: A392||Acute meningococcemia, (38) ICD-10 Condition: A400||Sepsis due to streptococcus, groupA, (39) ICD-10 Condition: A401||Sepsis due to streptococcus, groupB, (40) ICD-10 Condition: A403||Sepsis due to Streptococcus pneumoniae, (41) ICD-10 Condition: A408||Other streptococcal sepsis, (42) ICD-10 Condition: A410||Sepsis due to Staphylococcus aureus, (43) ICD-10 Condition: A411||Sepsis due to other specified staphylococcus, (44) ICD-10 Condition: A414||Sepsis due to anaerobes, (45) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (46) ICD-10 Condition: A419||Sepsis, unspecified organism, (47) ICD-10 Condition: A753||Typhus fever due to Rickettsia tsutsugamushi, (48) ICD-10 Condition: A759||Typhus fever, unspecified, (49) ICD-10 Condition: A799||Rickettsiosis, unspecified, (50) ICD-10 Condition: B349||Viral infection, unspecified, (51) ICD-10 Condition: A90||Dengue fever [classical dengue], (52) ICD-10 Condition: A91||Dengue hemorrhagic fever, (53) ICD-10 Condition: B179||Acute viral hepatitis, unspecified, (54) ICD-10 Condition: A988||Other specified viral hemorrhagicfevers, (55) ICD-10 Condition: A499||Bacterial infection, unspecified, (56) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.All adults patients admitted into ICU from ER with suspicion of community acquired infection and started on empirical antibiotics
2.Antibiotics started within 48 hours of admission to ICU and continued for atleast 24 hours.
|
|
| ExclusionCriteria |
| Details |
1.Patients with indwelling catheters (central venous catheters, haemodialysis catheters, urinary catheters, chemo port, peripherally inserted central catheter, etc) prior to admission
2.History of hospitalization for more than 2 days in the preceding 30 days
3.History of Antibiotic usage in the preceding 30 days
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Concordance with current guidelines
2.Appropriateness of empirical antibiotic therapy & its effect on Mortality at 28 days
|
28 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Appropriateness of empirical antibiotic therapy & its effect on ventilator free days at 28-day, vasopressor free days at 28-day, renal replacement therapy free days at 28-day, length of ICU stay and length of hospital stay |
28 days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
28/08/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
We seek to evaluate appropriateness of empirical antibiotic therapy for community acquired infections in critically ill patients and its effect on outcomes. We also seek to evaluate our concordance with current guidelines. Primary outcomes measured are mortality at 28 days. Secondary outcomes are ventilator free days, vasopressor free days, renal replacement free days at 28 days and length of ICU stay and hospital stay. ICMR guidelines and ISCCM guidelines for tropical illness are used to compare concordance. |