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Antibiotic use in patients who develop acute pancreatitis

PRocalcitonin guided Antibiotic use in Acute Pancreatitis Treatment Outcomes (PRoAbPTO): a randomized controlled trial - PRoAbPTO

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083715
Enrollment
84
Registered
2025-03-28
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: K85- Acute pancreatitis

Interventions

Intervention1: Piperacillin-tazobactum: Dose: 4.5 g. Frequency: every 8th hourly. Route of administration: Intravenous Duration: based on procalcitonin (PCT). Algorithm for administration: PCT wil

Sponsors

AIIMS Mangalagiri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 2. Valid informed consent 3. A diagnosis of acute pancreatitis requiring two of the following three features (as per revised Atlanta classification and definitions of acute pancreatitis, 2012) a. abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) b. serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal c. Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MR) or transabdominal ultrasonography (interstitial oedematous pancreatitis and necrotising pancreatitis

Exclusion criteria

Exclusion criteria: 1. Patients on immunosuppressive therapy 2. Immunocompromised patients (eg HIV, severe neutropenia) 3. Pre-existing organ dysfunctions (CKD, CHF, CVA with neurological deficits, CLD) 4. Acute pancreatis treated in outside facility with antibiotic usage more than 48 hours and referred cases

Design outcomes

Primary

MeasureTime frame
Duration of antibiotic usageTimepoint: 7 days

Secondary

MeasureTime frame
ICU length of stay Hospital length of stay Timepoint: 28 days, 90 days;Infection of pancreatic necrosis - defined either as a result of fine needle aspiration (FNA), radiological evidence of gas in a peri-pancreatic collection or positive microbiological cultures from surgical or post-mortem specimensTimepoint: 28 days, 90 days;d. Incidence of multi-resistant bacteria/microbes (clinical isolates resistant to 2 antibiotics as per sensitivity profile)Timepoint: 28 days, 90 days;Use of radiological, endoscopic or surgical interventionTimepoint: 28 days, 90 days;Re-admission to hospitalTimepoint: 28 days, 90 days;Survival - time-to-event (mortality) survival (Kaplan Maier)Timepoint: 90-days;Case fatality rateTimepoint: 28 days;Organ DysfunctionTimepoint: 28 days, 90 days

Countries

India

Contacts

Public ContactDr Mallikarjun Gunjiganvi

AIIMS Mangalagiri

gunjiganvi@gmail.com8860801346

Outcome results

None listed

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