Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis... | NCT04374188

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

NCT04374188

Sponsor

Diaa Eldin Taha Ramadan Mohamed

Status

Unknown status

Last Update Posted

Mar 3, 2021Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Nephrolithiasis

Interventions

Ciprofloxacin
Levofloxacin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Apr 18, 2020

First Submission Date that Met QC Criteria

May 1, 2020

First Posted Date

May 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diaa Eldin Taha Ramadan Mohamed, Lecturer of urology, Kafrelsheikh UniversitySponsor-Investigator

Lead Sponsor

Diaa Eldin Taha Ramadan MohamedOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ciprofloxacin	Active Comparator	ciprofloxacin tablets	Drug: Ciprofloxacin
levofloxacin	Active Comparator	levofloxacin tablets	Drug: Levofloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin	Drug	drug adminstration to ameliorate sepsis incidence	ciprofloxacin

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diaa Eldin Taha, MD	Contact	01008531384		drdiaaeldin@gmail.com
Hossam Nabeeh, MD	Contact			dr_hossam_nabeeh@yahoo.com

Overall Officials

Name	Affiliation	Role
Diaa Eldin Taha, MD	Lecturer of urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafrelsheikh faculty of medicine	Recruiting	Kafr ash Shaykh	Kafrelsheikh		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053040	Nephrolithiasis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002939	Ciprofloxacin
D015363	Quinolones
D064704	Levofloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided