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A study on relationship of dosage of Amikacin drug with levels in blood.

Optimization of Dosage Regimen of Amikacin: A Pharmacometric Approach

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/08/035823
Enrollment
60
Registered
2021-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

None listed

Sponsors

Manipal Center for infectious Diseases
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with sepsis: Infection site suspected, microbiological sampling done, and prescribed with Amikacin as part of therapeutic management. Patients whose age is > 18 and

Exclusion criteria

Exclusion criteria: Pregnant or lactating women Patients who are not willing to give informed consent Blood transfusion >4 units per week Patients on dialysis Patients with chronic kidney disease Inability to get consent of the patient or next of kin Second admission to ICU or previous enrolment in study (within same hospital admission)

Design outcomes

Primary

MeasureTime frame
Drug concentrations in blood and pharmacokinetic parameters like clearance, volume of distribution, half-life will be estimated. These parameters will be used for developing dosage protocol.Timepoint: First 8 months - Patient recruitment. Next 4 months - Analysis—

Secondary

MeasureTime frame
pharmacokinetic parameters like clearance, volume of distribution and half life of Amikacin.Timepoint: First 8 months - Patient recruitment. Next 4 months - Analysis—

Countries

India

Contacts

Public ContactDr Surulivelrajan M

Manipal College of Pharmaceutical Sciences, Manipal

msv.rajan@manipal.edu9886921414

Outcome results

None listed

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