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

NCT ID: NCT03178292

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2017-06-15

Brief Summary

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

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

Conditions

Percutaneous Nephrolithotomy; Infection; Sepsis; Antibiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Levofloxacin

Levofloxacin 500 mg daily for 5 days

Group Type: ACTIVE_COMPARATOR

Levofloxacin

Intervention Type: DRUG

Levofloxacin 500Mg daily for 5 days

Placebo

Placebo tab daily for 5 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Oral Tablet daily for 5 days

Interventions

Levofloxacin

Levofloxacin 500Mg daily for 5 days

Intervention Type: DRUG

Placebo

Placebo Oral Tablet daily for 5 days

Intervention Type: DRUG

Other Intervention Names

Levofloxacin 500Mg; placebo Oral Tablet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Shoma, MD

Role: STUDY_CHAIR

Urology and Nephrology center

Nasr Eltabey, MD

Role: STUDY_DIRECTOR

Urology and Nephrology center

Mahmoud Laimon, Msc

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Muhamad Abdullateef, Msc

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology center

Locations

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Countries

Egypt

Central Contacts

Abdelwahab R. Hashem, Msc

Role: CONTACT

abdelwahab_hashem@yahoo.com

01069678979 ext. 002

Facility Contacts

Abdelwahab R. Hashem, Msc

Role: primary

abdelwahab_hashem@yahoo.com

01069678979 ext. 002

Other Identifiers

Ab-PCNL

Identifier Type: -

Identifier Source: org_study_id