| CTRI Number |
CTRI/2025/02/080503 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [analytical] |
| Study Design |
Other |
|
Public Title of Study
|
THERAPEUTIC DRUG MONITORING OF ANTIMICROBIALS IN CRITICALLY ILL PATIENTS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN CRITICALLY ILL PATIENTS |
|
Scientific Title of Study
|
THERAPEUTIC DRUG MONITORING OF ANTIMICROBIALS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN CRITICALLY ILL PATIENTS |
| Trial Acronym |
TDM by HPLC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Rasheed Razia |
| Designation |
Assistant professor of Pharmacology |
| Affiliation |
Melmaruvathur Adhiparasakthi institue of medical sciences and research |
| Address |
Department of Pharmacology Melmaruvathur adhiparasakthi institue of medical sciences and research
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8220535495 |
| Fax |
|
| Email |
dr.raziaar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Rasheed Razia |
| Designation |
Assistant professor of Pharmacology |
| Affiliation |
Melmaruvathur Adhiparasakthi institue of medical sciences and research |
| Address |
Assistant professor
Department of Pharmacology
Melmaruvathur adhiparasakthi institue of medical sciences and research
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8220535495 |
| Fax |
|
| Email |
dr.raziaar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Rasheed Razia |
| Designation |
Assistant professor of Pharmacology |
| Affiliation |
Melmaruvathur Adhiparasakthi institue of medical sciences and research |
| Address |
Melmaruvathur adhiparasakthi institue of medical sciences and research
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
8220535495 |
| Fax |
|
| Email |
dr.raziaar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.Abdul Rasheed Razia |
| Address |
Assistant Professor of Pharmacology
Melmaruvathur 603319 |
| 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 |
| DrRazia |
Melmaruvathur Adhiparasakthi institue of medicial sciences and research |
chengalpattu district
Melmaruvathur
Kancheepuram
TAMIL NADU |
8220535495
dr.raziaar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MAPIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z71||Persons encountering health services for other counseling and medical advice, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood analysis |
Venous blood sample of 2ml will be collected in heparinized tube, mixed and stored in ice box will be transferred to central research lab. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ICU patients Started on fresh IV antibiotics after test dose |
|
| ExclusionCriteria |
| Details |
Patients on oral antimicrobials
Patients with TB/HIV
Sudden switch over to antibiotics without washout period
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to estimate the Plasma concentration of the administered drug |
30 mins post drug administration
trough level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for Drug toxicity in plasma concentration |
at the time of sample analysis by HPLC |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="3"
Months="3"
Days="3" |
|
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
|
BACKGROUD: The burden of infection is high in the intensive care unit (ICU) even after the consumption of antimicrobial agents (antibacterials, antifungals and antivirals). Hence, it is essential to optimise the use of antimicrobial agents not only to maximize therapeutic success but also to prolong the lifespan. For optimum clinical efficacy, Therapeutic drug monitoring (TDM) can be done which is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient’s bloodstream, thereby optimizing individual dosage regimens. TDM also helps to review pharmacokinetics (PK) and pharmacodynamics (PD) of antimicrobials which can limit the emergence of resistance. OBJECTIVE: 1. To identify the most commonly used antimicrobials in ICU. 2. To do therapeutic drug monitoring of antimicrobials by HPLC thereby estimating the plasma concentration of the given drug 3. To describe how TDM can be utilized to improve critically ill patient outcomes from severe infectionsMATERIALS AND METHODS: This study will be initiated after approval from IEC. Written informed consent will be obtained. STUDY POPULATION: patients admitted in ICU above 18 satisfying inclusion and exclusion criteria. SAMPLE SIZE: 100 calculated using sample size & statistics software based on previous study. STUDY SITE: Melmaruvathur Adhiparasakthi Institute of Medical Sciences And Research STUDY DURATION: 3 years STUDY CHEMICALS: Will be purchased from HI-MEDIA, SIGMA ALDRICH, MI. INSTRUMENTATION AND CHROMATOGRAPHIC CONDITIONS: Shimadzu HPLC CBM-20A SAMPLING TIME: TDM with two samples drawn at 1 (30-mins post completion of drug infusion) and 6–22 hours post administration SAMPLE PREPARATION AND VALIDATION:will be done as per the instrument manual. Specially designed case proforma will be used to collect all the relevant data. STATISTICAL ANALYSIS: HPLC allows description of peak concentrations and AUC using linear regression. The results will be tabulated and analyzed using SPSS 22.0. CONCLUSION: This research will provide a practical guide on how TDM can be applied in routine clinical practice to improve therapeutic outcomes, thereby minimizing the risk and toxicity in critically patients KEYWORDS: TDM, Antimicrobials, Pharmacokinetics, Pharmacodynamics |