Skip to content

Tracking Antibiotic Levels in ICU Patients: Can Monitoring Help Improve Recovery?

Systemic Exposure to Anti-infectives in Critical Care Units and the Role of Therapeutic Drug Monitoring in Improving Clinical Outcome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092601
Enrollment
242
Registered
2025-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A499- Bacterial infection, unspecified

Interventions

Intervention1: 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. Control Intervention1:

Sponsors

Believers Church Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients initiated on any one of the following antibiotics: meropenem, piperacillin, cefoperazone, ceftazidime, amikacin, gentamicin, colistin, polymyxin B, teicoplanin, vancomycin and linezolid.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Day 7 of antibiotic treatment

Secondary

MeasureTime frame
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 treatmentTimepoint: 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.Timepoint: Day 7 of antibiotic treatment

Countries

India

Contacts

Public ContactPhilip Mathew

Believers Church Medical College Hospital

philipmathew@bcmch.edu.in914692742806

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026