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Study of use of drugs used to treat bacterial infections and measuring vancomycin drug levels

Antibacterial Utilization Study in a Tertiary Care Pediatric Intensive Care Unit with Estimation of Drug Levels of Vancomycin - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065210
Enrollment
400
Registered
2024-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: K929- Disease of digestive system, unspecified Health Condition 2: N289- Disorder of kidney and ureter, unspecified Health Condition 3: R99- Ill-defined and unknown cause of mortality Health Condition 4: A498- Other bacterial infections of unspecified site Health Condition 5: G988- Other disorders of nervous system Health Condition 6: J22- Unspecified acute lower respiratory infection Health Condition 7: I999- Unspecified disorder of circulatory system

Interventions

Intervention1: Collection of blood sample for estimation of drug levels of vancomycin: Collection of blood sample for estimation of drug levels of vancomycin in 12 patients. Details given in next sect

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consecutive patients in the age group of more than 1 month to 12 years who are newly admitted to the PICU and are started on antibacterial agents. 2. For estimation of vancomycin levels, 12 patients on vancomycin will be enrolled from amongst the above study participants.

Exclusion criteria

Exclusion criteria: Patients for whom the parents / guardians are not willing to give informed consent for participation will be excluded.

Design outcomes

Primary

MeasureTime frame
1. Utilization of antibacterial agents as per the World Health Organization (WHO) drug use indicators. 2. Indications of using antibacterial agents (empirical OR definitive OR prophylactic). 3. Indications for change of antibacterial agents and escalation OR de-escalation of antibacterial agents. Timepoint: Duration of the PICU stay till discharge or death

Secondary

MeasureTime frame
1. Estimate the drug levels of vancomycin. 2. Off-label use of antibacterial agents Timepoint: Duration of the PICU stay till discharge or death

Countries

India

Contacts

Public ContactSubashree S

Seth G.S. Medical College and KEM Hospital

milindtullu@yahoo.com9869469974

Outcome results

None listed

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