Antibiotic therapy and its effect on organ dysfunction in burns patient.

Effect of systemic antimicrobial prophylaxis on early organ dysfunction in Burn Patients: an open-labelled randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082708

Enrollment

300

Registered

2025-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: T312- Burns involving 20-29% of body surface Health Condition 2: T313- Burns involving 30-39% of body surface Health Condition 3: T314- Burns involving 40-49% of body surface Health Condition 4: T315- Burns involving 50-59% of body surface Health Condition 5: T316- Burns involving 60-69% of body surface

Interventions

Intervention1: Piperacillin-tazobactam antibiotic prophylaxis: Antibiotic prophylaxis administered to adult burns patients with (20-70) % TBSA for 14 days Control Intervention1: Standard of care witho

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients in the age group (18 to 65 years). 2. Burns with greater than 20% and up to 70% of TBSA involved. 3. Length of ICU stay greater than 3 complete days. 4. Burns to admission to ICU duration less than 48 hours.

Exclusion criteria

Exclusion criteria: 1. Consent refusal 2. Allergy to piperacillin-tazobactam 3. Pregnancy or lactating female 4. Significant pre-existing comorbidities – CKD 4/5, CLD 5. Already receiving antibiotic for other causes 6. Length of ICU stay less than or equal to 3 complete days (due to either early death or brief admission for monitoring) 7. Burns due to non-thermal injury (such as chemical or electrical burns)

Design outcomes

Primary

Measure	Time frame
To determine average daily SOFA score from day one of enrolment til l14 days in adult burns patients with 20-70% total body surface area involved.Timepoint: At ICU admission (baseline) and daily till 14 days.	—

Secondary

Measure	Time frame
Rate of occurrence of secondary sepsis due to micro-organismsTimepoint: admission till 14 days;Piperacillin-tazobactam antibiotic resistance patternTimepoint: admission till 14 days;Incidence of acute kidney injury, antibiotic associated diarrhoea etc.Timepoint: admission to 14 days;Mortality in patientsTimepoint: admission till 90 days;ICU length of stayTimepoint: total duration of ICU stay	—

Countries

India

Contacts

Public ContactJabed Ahmed

AIIMS, New Delhi

darlongv@yahoo.com9821607809

Outcome results

None listed

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