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A study on monitoring the Drug Levels of Antibiotics Like Amikacin and Vancomycin: A Clinical 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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096694
Enrollment
30
Registered
2025-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1. Proportion of patients who achieved their drug levels within the therapeutic range. 2. Proportion of patients in whom adverse effects like nephrotoxicity were reducedTimepoint: 3 time point (trough- before the drug, 2 peak time points)—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Renuka Munshi

TN Medical College & BYL Nair Hospital

renuka.munshi@gmail.com02223027205

Outcome results

None listed

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