Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial

Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

Study Overview

• Status: Recruiting
• Conditions: Nephrolithiasis
• Intervention / Treatment: Drug: Ciprofloxacin; Drug: Levofloxacin

Detailed Description

To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hossam Nabeeh, MD; Email: dr_hossam_nabeeh@yahoo.com

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt
      • Recruiting
      • Kafrelsheikh faculty of medicine
      • Sub-Investigator: Hossam Nabeeh, MD

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:

• 1. Patient 18 years or older
• Stones ≥ 2 cm and/or mild to moderate hydronephrosis
• Sterile mid urine stream

Exclusion Criteria:

• Patients with a stent, nephrostomy tube or indwelling catheter
• Renal failure
• Fever before surgery
• Previous manipulation/procedure
• 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: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ciprofloxacin; ciprofloxacin tablets	Drug: Ciprofloxacin; drug adminstration to ameliorate sepsis incidence; Other Names: quinolones
ACTIVE_COMPARATOR: levofloxacin; levofloxacin tablets	Drug: Levofloxacin; levofloxacin pill; Other Names: quinolones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of ciprofloxacin versus levofloxacin duration before PCNL	To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine	Compare the difference between C&S of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone, in predicting the upper urinary tract infection and urosepsis.	12 months
predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.	assess the risk factors for SIRS and sepsis in PCNL.	12 months

Collaborators and Investigators

• Sponsor: Diaa Eldin Taha Ramadan Mohamed

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis; 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; Ciprofloxacin; Levofloxacin; Ofloxacin
• Other Study ID Numbers: RS/19.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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