Preventing Antibiotic-Associated DiarRhea Using Erceflora (PADRE)

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00447161

First received: March 13, 2007

Last updated: September 4, 2008

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2007

Last Updated Date

September 4, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction in the incidence of antibiotic-associated diarrhea (relative risk) [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
All adverse event regardless of seriousness or relationship to the study drug [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
Safety Outcome: All adverse event regardless of seriousness or relationship to the study drug

Change History

Complete list of historical versions of study NCT00447161 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction in the number of antibiotic-associated diarrhea events per day [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
Reduction in the severity of diarrhea events [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups. [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
Reduction in C. dificille -associated diarrhea. [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Reduction in the number of antibiotic-associated diarrhea events per day
Reduction in the severity of diarrhea events
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.
Reduction in C. dificille -associated diarrhea.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Preventing Antibiotic-Associated DiarRhea Using Erceflora

Official Title ^ICMJE

Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety

Brief Summary

To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diarrhea, Infantile

Intervention ^ICMJE

Drug: Bacillus Clausii Multi ATB Resist
Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
Drug: Placebo
Matched placebo

Study Arm (s)

Experimental: 1
Bacillus Clausii Multi ATB Resist

Intervention: Drug: Bacillus Clausii Multi ATB Resist
Placebo Comparator: 2
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

323

Completion Date

Not Provided

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.

Exclusion Criteria:

Children with unstable medical condition
In any form of immunocompromized state
With contraindication to take medication
Has taken antibiotics for 3 weeks before start of trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender

Both

Ages

6 Months to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Philippines

Administrative Information

NCT Number ^ICMJE

NCT00447161

Other Study ID Numbers ^ICMJE

ENTER_L_01125

Has Data Monitoring Committee

Not Provided

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Paz Figueroa

Sanofi

Information Provided By

Sanofi

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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