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A RANDOMIZED CONTROL TRIAL TO STUDY THE VARIATION OF PLASMA CONCENTRATIONS OF ONCE DAILY INTRAVENOUS VERSUS INTRAMUSCULAR GENTAMICIN IN INFANTS

A RANDOMIZED CONTROL TRIAL TO STUDY THE PHARMACOKINETICS OF ONCE DAILY INTRAVENOUS VERSUS INTRAMUSCULAR GENTAMICIN IN INFANTS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/03/005622
Enrollment
90
Registered
2015-03-11
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: null- Infants age less than 6 months suffering from bacterial infections

Interventions

Intervention1: Intramuscular Gentamicin: Infants found suitable as per inclusion criteria were administered intramuscular gentamicin (5mg/kg). Blood samples (2ml) were taken from each patient to deter

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All infants of age less than or equal to 6 months admitted to a Paediatric unit of Kalawati Saran Children Hospital, New Delhi with suspected or confirmed infections considered suitable for gentamicin therapy such as, i. Suspected Gram-negative sepsis, ii. Infections like acute enteritis, pneumonia, meningitis and septic arthritis, and iii. Urinary tract infection (UTI)

Exclusion criteria

Exclusion criteria: i. Age greator than 6 months ii. Abnormal renal functions (serum urea and creatinine). iii. Earlier diagnosed cases of impaired internal ear function or deafness. iv. Severely ill patients or those with life-threatening infections.

Design outcomes

Primary

MeasureTime frame
Peak and Trough serum gentamicin concentrations (SGCs) post single dose of intravenous gentamicin and intramuscular gentamicin injections.Timepoint: After 30 minutes and 60 minutes of IV and IM administration of gentamicin respectively, to determine serum peak levels of gentamicin. To estimate trough serum gentamicin levels after 18 hours of administration of gentamicin by either route.

Secondary

MeasureTime frame
No secondary OutcomesTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Sumit Kumar Kulhare

Lady Hardinge Medical College, New Delhi

harmeetrehan@hotmail.com09711709148

Outcome results

None listed

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