Antibiotics in the prevention of burn related wound infection

Systemic antimicrobial prophylaxis in critically ill burns patients- An open label randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073700

Enrollment

800

Registered

2024-09-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: T300- Burn of unspecified body region, unspecified degree

Interventions

Intervention1: Injection Piperacillin tazobactam : Injection Piperacillin tazobactam Dose: 4.5g three times daily Route : Intravenous Duration: 14 days Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients with (18 – 65 years) 2. Burns with greater than 20% to 70% of total body surface area involvement

Exclusion criteria

Exclusion criteria: 1. Refusal to consent 2. Patient allergic to piperacillin tazobactam 3. Pregnancy or breast feeding 4. Significant pre-existing comorbidities – CKD 4/5, CLD 5. Receiving antibiotic for any other reason

Design outcomes

Primary

Measure	Time frame
28 day mortalityTimepoint: 28 day after randomisation	—

Secondary

Measure	Time frame
1. Rate of occurrence of secondary sepsis due to MDR organisms(diagnosed by increase in SOFA- classified into CAUTI, CRBSI, HAP/VAP, Wound sepsis) 2. Need for escalation of antibiotics due to secondary sepsis 3. ICU LOS 4. Incidence of treatment related adverse events – AKI, antibiotic-associated diarrhoea, bone marrow suppression, etc. 5. 90 day mortality Timepoint: upto 90 days after randomisation	—

Measure

Time frame

1. Rate of occurrence of secondary sepsis due to MDR organisms(diagnosed by increase in SOFA- classified into CAUTI, CRBSI, HAP/VAP, Wound sepsis) 2. Need for escalation of antibiotics due to secondary sepsis 3. ICU LOS 4. Incidence of treatment related adverse events – AKI, antibiotic-associated diarrhoea, bone marrow suppression, etc. 5. 90 day mortality Timepoint: upto 90 days after randomisation

—

Countries

India

Contacts

Public ContactPriyankar Datta

AIIMS, Newdelhi

drrajathadri@gmail.com9886936414

Outcome results

None listed

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