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Impact of duration of administration of pre-operative antibiotics to prevent infection after PNL

Impact of duration of administration of pre-operative antibiotics on SIRS/urosepsis rates in patients undergoing PNL for non-staghorn renal stones: A randomized controlled study.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041857
Enrollment
120
Registered
2022-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: N200- Calculus of kidney

Interventions

Intervention1: preoperative antibiotic (levofloxacin) of different duration: Group II: Those receiving Tab. Levofloxacin 500 mg for a day prior to surgery (once a day) and Inj. Levofloxacin 500 mg at

Sponsors

Director PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients > 18 years of age 2.Patients with non-staghorn unilateral renal calculi 3.Patients with no indwelling ureteral stent or percutaneous nephrostomy tube in the ipsilateral or contralateral side 4.Patients with sterile mid-stream urine culture at the time of recruitment 5.Patients with a prior positive urine culture (without resistance to fluoroquinolones) in the past, but a sterile urine culture at the time of recruitment 6.Patients without symptoms of UTI, prior to intervention (PNL)

Exclusion criteria

Exclusion criteria: 1.Patients 2.Patients with immunodeficiency (e.g., HIV-AIDS, uncontrolled diabetes mellitus, immunodeficiency syndromes) 3.Patients with fever before the surgery, regardless of the initiation of pre-operative antibiotics 4.Patients unfit for general anaesthesia 5.Patients with a known potential focus of sepsis elsewhere in the body 6.Patients without the mental capacity to give consent for the procedure 7.Patients unwilling to participate in the trial

Design outcomes

Primary

MeasureTime frame
To observe the number of participants who develop SIRS/sepsis after PNL, following different preoperative antibiotic duration.Timepoint: 48 hours

Secondary

MeasureTime frame
To determine the appropriate antibiotic (oral levofloxacin) duration (5 days versus 1 day) before PNL, in preventing post-PNL SIRS/urosepsis as assessed by clinical, biochemical, and microbiological parameters.Timepoint: 48 hours

Countries

India

Contacts

Public ContactRohit Deshpande

PGIMER, Chandigarh

uttammetepgi@gmail.com9914209322

Outcome results

None listed

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