NCT00591357

Brief Summary

To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and mortality of this serious nosocomial infection in patients who have antibiotic-associated diarrhea. Both C. diff positive and negative patients will be included.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

6.2 years

First QC Date

December 31, 2007

Last Update Submit

May 2, 2016

Conditions

Antibiotic-Associated DiarrheaClostridium Difficile

Keywords

Antibiotic associated diarrheaClostridium difficileloperamide

Outcome Measures

Primary Outcomes (1)

  • To determin symptomatic treatment of diarrhea with loperamide in antibiotic associated diarrhea

    2 years

Secondary Outcomes (1)

  • To measure the safety and efficacy of loperamide in the control of antibiotic associated diarrhea in hospitalized patients

    2 years

Study Arms (2)

A

ACTIVE COMPARATOR

Loperamide

Drug: loperamide

B

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

loperamideDRUG

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

A
placeboDRUG

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diarrheal stools considered to be antibiotic associated

You may not qualify if:

  • Inability of sign consent
  • Patient with other known gastrointestinal disease
  • Patients receiving tube feeding or fecal incontinence prior to receiving antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VAMC

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Loperamide

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Daniel M Musher, MD

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 11, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2013

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

US(1)