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A parallel two arm study to Compare 24 hours vs 48 hours Antibiotic Use in patients with positive urine culture after Endo-Urological Surgeries.

A Prospective, Randomized, Single-Center, Non-Inferiority Clinical Trial Comparing 24-Hour versus 48-Hour Post-Surgical Antibiotics Prophylaxis in Endo-Urological Surgeries with Positive Urine Culture - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088537
Enrollment
98
Registered
2025-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: N399- Disorder of urinary system, unspecified

Interventions

Intervention1: 24-hour Post-Surgical Regimen: Preoperative dose as per institutional protocol Postoperative: Continue same antibiotic(s) for 24 hours Control Intervention1: 48-hour Post-Surgical Regi

Sponsors

Indus International Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Positive urine culture prior to surgery Procedures defined as: Surgeries with entry into the urinary tract Procedure types: URS, PCNL, TURP, TURBT, OIU

Exclusion criteria

Exclusion criteria: Active systemic infection at time of surgery Presence of infective or matrix stone Presence of pus in the urinary tract infection or prostate Uncontrolled diabetes HbA1c more than 8 Antibiotic use within 7 days before surgery Known allergy to study antibiotics Severe renal or hepatic impairment Immunocompromised status Pregnancy or breastfeeding Participation in another interventional trial

Design outcomes

Primary

MeasureTime frame
Incidence of UTI/febrile UTI/SIRS (systemic inflammatory response syndrome) in immediate post-op period till discharge and within 30 days of surgery, defined by CDC criteriaTimepoint: Day before surgery Day of surgery Day 1 post surgery Day 2 Post surgery Day of discharge Day 30

Secondary

MeasureTime frame
Prevalence of bacteriuria at 30day follow-up Need for additional antibiotic treatment within 30 days Hospital length of stay Hospital readmission within 30 days Healthcare costs Antibiotic associated adverse events Timepoint: Day before surgery Day of surgery Day 1 post surgery Day 2 Post surgery Day of discharge Day 30

Countries

India

Contacts

Public ContactDharmender Singh Lather

Indus International Hospital

rajan927@yahoo.com09781259923

Outcome results

None listed

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