Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy

NCT03178292 | Unknown DMC

• 1 other identifier: Ab-PCNL
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after PCNL.

Conditions

Percutaneous Nephrolithotomy; Infection; Sepsis; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference

  SIRS if patient has Two or more of the 4 SIRS criteria

  1 year

Secondary Outcomes (1)

• difference between culture and sensitivity of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone.

  1 year

Study Arms (2)

Levofloxacin

ACTIVE COMPARATOR

Levofloxacin 500 mg daily for 5 days

Drug: Levofloxacin

Placebo

PLACEBO COMPARATOR

Placebo tab daily for 5 days

Drug: Placebo

Interventions

Levofloxacin DRUG

Levofloxacin 500Mg daily for 5 days

Also known as: Levofloxacin 500Mg

Levofloxacin

Placebo DRUG

Placebo Oral Tablet daily for 5 days

Also known as: placebo Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stones ≥ 2.5 cm and/or hydronephrosis
• Sterile mid urine stream

You may not qualify if:

• Patients with a stent, nephrostomy tube or indwelling catheter
• Uncontrolled Diabetes mellitus
• Renal failure
• Fever before surgery
• Concomitant bladder stone or tumour
• Patients with active UTI
• Contralateral renal/ureteric stone

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Infections; Sepsis

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ahmed Shoma, MD

  Urology and Nephrology center

  STUDY CHAIR

• Nasr Eltabey, MD

  Urology and Nephrology center

  STUDY DIRECTOR

• Mahmoud Laimon, Msc

  Urology and Nephrology center

  PRINCIPAL INVESTIGATOR

• Muhamad Abdullateef, Msc

  Urology and Nephrology center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelwahab R. Hashem, Msc

CONTACT

01069678979; abdelwahab_hashem@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 6, 2017
• Study Start: June 15, 2017
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: June 6, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)