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

NCT04374188 | Unknown DMC

• 1 other identifier: RS/19.23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine

  12 months

• predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.

  12 months

Study Arms (2)

ciprofloxacin

ACTIVE COMPARATOR

ciprofloxacin tablets

Drug: Ciprofloxacin

levofloxacin

ACTIVE COMPARATOR

levofloxacin tablets

Drug: Levofloxacin

Interventions

Ciprofloxacin DRUG

drug adminstration to ameliorate sepsis incidence

Also known as: quinolones

ciprofloxacin

Levofloxacin DRUG

levofloxacin pill

Also known as: quinolones

levofloxacin

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diaa Eldin Taha Ramadan Mohamed: lead

Study Sites (1)

Kafrelsheikh faculty of medicine

Kafr ash Shaykh, Kafrelsheikh, Egypt

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Ciprofloxacin; Quinolones; Levofloxacin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Diaa Eldin Taha, MD

  Lecturer of urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diaa Eldin Taha, MD

CONTACT

01008531384; drdiaaeldin@gmail.com

Hossam Nabeeh, MD

CONTACT

dr_hossam_nabeeh@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of urology

Model Details: Efficacy of ciprofloxacin therapy in sepsis avoidance.

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: May 5, 2020
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)