Comparative Study of Rifaximin Versus Norfloxacin in the... | NCT02120196

Studies
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

NCT02120196

Sponsor

Sherief Abd-Elsalam

Status

Unknown status

Last Update Posted

Jan 9, 2018Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Spontaneous Bacterial Peritonitis
Ascites
Liver Cirrhosis

Interventions

Rifaximin
Norfloxacin

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

Jan 2018

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

Jan 2014

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Apr 7, 2014

First Submission Date that Met QC Criteria

Apr 18, 2014

First Posted Date

Apr 22, 2014Estimated

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

Jan 5, 2018

Last Update Posted Date

Jan 9, 2018Actual

Name	Class
Tanta University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.

Detailed Description

This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups :

Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rifaximin	Experimental	Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.	Drug: Rifaximin
norfloxacin	Active Comparator	Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.	Drug: Norfloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug	rifaximin 1200 mg daily versus norfloxacin 400 mg once daily	rifaximin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with recurrence of SBP	The total number of paper of participitants with recurrence of SBP	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previous episode of SBP
Total protein in the ascitic fluid below or equal to 1.5 g/dL

Exclusion Criteria:

Allergy to quinolones
Antibiotic therapy in the 2 weeks preceding inclusion
Recent ( within the previous 2 weeks) episode of digestive hemorrhage
Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
Pregnant and lactating women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief M. Abd-Elsalam, Lecturer	Contact	00201000040794		Sheif_tropical@yahoo.com

Overall Officials

Name	Affiliation	Role
Asem A Elfert	TUH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta university hospital	Recruiting	Tanta			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D001201	Ascites
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078262	Rifaximin
D009643	Norfloxacin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided