| CTRI Number |
CTRI/2025/10/096694 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on monitoring the Drug Levels of Antibiotics Like Amikacin and Vancomycin: A Clinical Study |
|
Scientific Title of Study
|
An Exploratory Clinical Study to assess the role of Therapeutic Drug Monitoring of Amikacin and Vancomycin in achieving target drug levels and reducing Adverse Drug Events in Hospitalised Patients |
| 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 Renuka Munshi |
| Designation |
Professor & Head, Department of Clinical Pharmacology |
| Affiliation |
TN Medical College & BYL Nair Hospital |
| Address |
G building, 5th Floor, Department of Clinical Pharmacology, Dr. AL Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027205 |
| Fax |
|
| Email |
renuka.munshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka Munshi |
| Designation |
Professor & Head, Department of Clinical Pharmacology |
| Affiliation |
TN Medical College & BYL Nair Hospital |
| Address |
G building, 5th Floor, Department of Clinical Pharmacology, Dr. AL Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027205 |
| Fax |
|
| Email |
renuka.munshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka Munshi |
| Designation |
Professor & Head, Department of Clinical Pharmacology |
| Affiliation |
TN Medical College & BYL Nair Hospital |
| Address |
G building, 5th Floor, Department of Clinical Pharmacology, Dr. AL Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027205 |
| Fax |
|
| Email |
renuka.munshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| TNMC & BYL Nair Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Renuka Munshi |
TN Medical College & BYL Nair Hospital |
G building, 5th Floor, Department of Clinical Pharmacology, Dr. AL Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA |
02223027205
renuka.munshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients admitted in the ICU and/or wards in whom intravenous amikacin or vancomycin therapy is initiated for proven or suspected Gram-negative (amikacin) or Gram-positive (vancomycin) infections
2. Patients or LAR willing to give consent for the study |
|
| ExclusionCriteria |
| Details |
1. Patients who are hemodynamically unstable in form of intubation, shock requiring ionotropes.
2. Patients who need other antibiotics for their clinical management
3. Patients not willing to give consent for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients who achieved their drug levels within the therapeutic range.
2. Proportion of patients in whom adverse effects like nephrotoxicity were reduced |
3 time point (trough- before the drug, 2 peak time points) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/11/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Therapeutic drug monitoring TDM plays a crucial role in drugs with narrow therapeutic indices such as aminoglycosides amikacin and glycopeptides vancomycin where small dosing changes can significantly impact efficacy or toxicity
Both amikacin and vancomycin are critical narrow spectrum antibiotics frequently used in the treatment of severe infections particularly in critically ill patients
However these drugs possess a narrow therapeutic index meaning that the range between an effective and a toxic dose is small
For amikacin subtherapeutic dosing risks treatment failure and fosters the development of resistant Gram negative organisms while overdosing significantly increases the likelihood of nephrotoxicity and ototoxicity particularly in patients with renal dysfunction or prolonged therapy durations
Similarly vancomycin underdosing may lead to persistent bacteraemia and resistance especially in Staphylococcus aureus infections while overdosing is associated with acute kidney injury AKI
This is particularly problematic in the ICU where altered pharmacokinetics due to sepsis fluid shifts and organ dysfunction amplify inter individual variability
As such precise dosing guided by Therapeutic Drug Monitoring TDM is essential to ensure efficacy while minimizing toxicity
Hence we are planning to do TDM in critically ill patients as these patients often have altered and unpredictable pharmacokinetics due to changes in volume of distribution organ dysfunction and use of extracorporeal support
Also TDM allows individualized dosing based on measured drug concentrations reducing the risk of toxicity and increasing the probability of target attainment
This study outlines evidence based strategies for the implementation of TDM to maximize therapeutic efficacy while minimizing adverse effects |