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

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

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

Study Overview

• Status: Unknown
• Conditions: Sepsis; Infection; Antibiotics; Percutaneous Nephrolithotomy
• Intervention / Treatment: Drug: Levofloxacin; Drug: Placebo

Detailed Description

Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of large volume upper urinary tract stones. Although PCNL is effective and yielding high stone-free rates, complications rates range from 18.30% to 83% with sepsis has been reported in 0.3% to 7.6% of cases result in the most common cause of perioperative mortality in PCNL patients.

Urosepsis after PNL is an important and potentially catastrophic complication. The overall incidence of fever (25%), bacteremia (23%), endotoxemia (34%) and septicemic shock occurs in 0.3%-2.5% of patients. Urosepsis and shock result from the intravasation of bacteria or endotoxins into bloodstream, which in turn increases with prolonged surgery, degree of hydronephrosis, bacterial load in the renal pelvis, and presence of infected stones.

Charton et al., concluded that without antibiotic prophylaxis 35% of patient suffered urinary tract infection a post-PCNL, although preoperative urine showing no growth. In a prospective but nonrandomized assessment of PCNL patients receiving oral ciprofloxacin, intravenous ciprofloxacin, or no antimicrobial treatment found postoperative urinary tract infection to occur in 17%, 0%, and 40% of patients, respectively. Mariappan et al., stated that midstream urine (MSU) culture does not represent upper tract infection in patients with obstructing stones. Also, stone and pelvic urine cultures are better predictors of upper tract infection and urosepsis in such cases.

Antibiotic prophylaxis has been recommended (Level of evidence: IIb, III) for patients subjected to PCNL to avert these infectious complications, as profiled in an American Urological Association (AUA) Best Practice Policy Statement. They also recommend antibiotic prophylaxis before shock wave lithotripsy and ureteroscopy with high level (Level of evidence: Ia and Ib, respectively) due to presence of meta-analysis and large randomised controlled trial.

The optimal timing, dosing, and duration of a prophylactic antibiotic regimen for PCNL procedures has also been a point of discussion. The AUA best practice policy statement currently recommends that a one-time dose on the day of the procedure is sufficient. The EAU guidelines are less definitive in concluding that a short course is adequate but that the "length of time is to be determined." Mariappan and colleagues in a prospective non-randomised trial found that 52 patients who had dilated collecting systems, stone burden greater than 2 cm, and no confounding factors predisposing to UTIs who received a 1-week course of ciprofloxacin before PCNL had a 3-fold lower risk of postoperative UTI and SIRS than 46 patients who received standard perioperative antibiotics on the day of surgery.

Bag and colleagues prospectively randomized 101 patients with greater than 2.5-cm kidney stones and/or hydronephrosis with sterile preoperative urine cultures to a 7-day course of nitrofurantoin versus no antibiotics before PCNL and found a statistically significant lower rate of postoperative SIRS (19% vs 49%), endotoxemia (18% vs 42%), positive result on kidney urine culture (0% vs 10%), and positive result on stone culture (8% vs 30%) in the arm receiving nitrofurantoin.

Although these two small series support a week of preoperative antibiotics before PCNL, larger, prospective, randomized studies are needed to better elucidate the risks and benefits of empiric antibiotics

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aldakahlia
    • Mansoura, Aldakahlia, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Levofloxacin; Levofloxacin 500 mg daily for 5 days	Drug: Levofloxacin; Levofloxacin 500Mg daily for 5 days; Other Names: Levofloxacin 500Mg
PLACEBO_COMPARATOR: Placebo; Placebo tab daily for 5 days	Drug: Placebo; Placebo Oral Tablet daily for 5 days; Other Names: placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference between culture and sensitivity of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone.	Preoperative urine (MSU),intraoperative renal pelvic urine and extracted stone culture and sensitivity.	1 year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmed Shoma, MD, Urology and nephrology center; Principal Investigator: Muhamad Abdullateef, Msc, Urology and nephrology center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 15, 2017
• Primary Completion (ANTICIPATED): June 15, 2017
• Study Completion (ANTICIPATED): June 15, 2017

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: Ab-PCNL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No