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CTRI Number  CTRI/2025/08/092601 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Tracking Antibiotic Levels in ICU Patients: Can Monitoring Help Improve Recovery? 
Scientific Title of Study   Systemic Exposure to Anti-infectives in Critical Care Units and the Role of Therapeutic Drug Monitoring in Improving Clinical Outcome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Philip Mathew 
Designation  Head of department, Department of Critical care 
Affiliation  Believers Church Medical College Hospital 
Address  Department of Critical Care, Believers Church Medical College Hospital, Kuttapuzha, Thiruvalla

Pathanamthitta
KERALA
689103
India 
Phone  914692742806  
Fax    
Email  philipmathew@bcmch.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Philip Mathew 
Designation  Head of department, Department of Critical care 
Affiliation  Believers Church Medical College Hospital 
Address  Department of Critical Care, Believers Church Medical College Hospital, Kuttapuzha, Thiruvalla

Pathanamthitta
KERALA
689103
India 
Phone  914692742806  
Fax    
Email  philipmathew@bcmch.edu.in  
 
Details of Contact Person
Public Query  
Name  Philip Mathew 
Designation  Head of department, Department of Critical care 
Affiliation  Believers Church Medical College Hospital 
Address  Department of Critical Care, Believers Church Medical College Hospital, Kuttapuzha, Thiruvalla

Pathanamthitta
KERALA
689103
India 
Phone  914692742806  
Fax    
Email  philipmathew@bcmch.edu.in  
 
Source of Monetary or Material Support  
Believers Church Medical College Hospital, Kuttapuzha, Thiruvalla, Kerala, India - 689103 
 
Primary Sponsor  
Name  Believers Church Medical College Hospital 
Address  Kuttapuzha, Thiruvalla - 689103 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Philip Mathew   Believers Church Medical College Hospital  Department of Critical Care, Believers Church Medical College Hospital, Kuttapuzha, Thiruvalla, Kerala, India 689103
Pathanamthitta
KERALA 		 914692742806

philipmathew@bcmch.edu.in  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A499||Bacterial infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active TDM Arm (Phase B)  Evaluation of target concentration attainment and dose optimization on three different days in the initial 7 days of antibiotic therapy. 
Comparator Agent  No TDM arm (Phase A)  Patients will receive standard of care treatment and dose optimization will be performed based on clinicians discretion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients initiated on any one of the following antibiotics: meropenem, piperacillin, cefoperazone, ceftazidime, amikacin, gentamicin, colistin, polymyxin B, teicoplanin, vancomycin and linezolid. 
 
ExclusionCriteria 
Details  Phase A and B
Patients who will be lost to follow up within 7 days after initiating one of the above-mentioned antibiotics.
Cessation of antibiotic before first sample collection for estimation of drug concentration.
Patients without an arterial line on the first day of sample collection
Patient continuing on empirical antibiotic without culture proven bacterial infection for 7 days.

Phase B
When the advice from TDM team for dose optimization is not followed in the initial 5 days of antibiotic dosing.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare clinical outcome at day 7 of antibiotic administration between patients who were dose optimized based on TDM reports for antibiotics and those who were not dose optimized based on TDM reports.  Day 7 of antibiotic treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To study the systemic exposure to the antibiotics meropenem, piperacillin, cefoperazone, ceftazidime, amikacin, gentamicin, colistin, polymyxin B, teicoplanin, vancomycin and linezolid among the patients who receive these antibiotics on day 2/3, day 4/5 and day 6/7 from the initiation of antibiotic treatment  Day 2 or 3, day 4 or 5 and day 6 or 7 of antibiotic treatment 
To compare the proportion of patients who develop acute kidney injury or neurotoxicity at day 7 of antibiotic administration between patients who were dose optimized based on TDM reports for antibiotics and those who were not dose optimized based on TDM reports.  Day 7 of antibiotic treatment 
 
Target Sample Size   Total Sample Size="242"
Sample Size from India="242" 
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   Phase 4 
Date of First Enrollment (India)   18/08/2025 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [precisionmedicine@bcmch.edu.in].

  6. For how long will this data be available start date provided 15-09-2027 and end date provided 14-09-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Hypothesis:
The real time therapeutic drug monitoring (TDM) leads to better clinical outcomes and reduced toxicity in critically ill patients compared to dose adjustments performed according to clinician’s discretion.

Purpose: 
This interventional study will be performed to evaluate the clinical utility of real time TDM in optimizing anti-infective dosing and improving outcomes in ICU patients. 
Study method:
In Phase A, we will recruit 121 critically ill patients based on the study selection criteria and will provide standard care dose adjustments based on clinicians discretion, without any TDM intervention. We will collect trough and Cmax blood samples for evaluation of antibiotic target achievement for evaluation at the end of phase A patient recruitment. 
In Phase B, we will recruit 121 critically ill patients based on the study selection criteria and will perform dose optimization based on TDM reports on day 2 or 3, day 4 or 5 and day 6 or 7 and will assess clinical outcome in day 7.
 
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