Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea (Concisus2012)

July 3, 2014 updated by: University of Aarhus

Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea

A randomized, double-blind, placebo-controlled clinical trial of azithromycin in Campylobacter concisus culture positive patients with diarrhea. The clinical characteristics of emerging Campylobacter concisus in adults is vomiting and persistent diarrhea. Whether patients may benefit from antibiotic treatment is unknown. The purpose of this trial is to investigate whether antibiotic treatment with azithromycin of Campylobacter concisus induced diarrhea can better the symptoms and shorten the duration of illness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Department of Infectious Diseases, Aalborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with culture-positive stool sample with Campylobacter concisus
  • Diarrheic patients ≥ 18 years
  • symptoms of diarrhea defined as three or more watery stools per day or
  • two watery stools per day + at least one of the following symptoms: abdominal pain, nausea, vomiting or fever.
  • Diarrheic symptoms for a minimum of 24 hours before enrollment.
  • Diarrheic symptoms for a maximum of 21 days before enrollment.
  • Informed oral and signed written consent, with documentation that all relevant information about the study is given to the patient.
  • The patient must be willing and able to participate in the trial.

Exclusion Criteria:

  • Hypersensitivity to azithromycin, erythromycin, macrolide or other ketolide-antibiotics
  • Pregnancy or breastfeeding (if relevant).
  • Culture positive stool sample with a Co-pathogen.
  • Treatment with other antibiotics (in any stage 21 days before the first stool sample).
  • Patients with severe liver disease.
  • Patients with severe renal impairment (GFR <10 ml / min).
  • Patients with congenital or documented acquired QT prolongation.
  • Patients treated with other active drugs that prolong the QT interval such as: antiarrhythmics of classes IA and III, cisapride and terfenadine.
  • Patients with electrolyte disorders, particularly hypokalemia and hypomagnesemia.
  • Patients with clinically relevant bradycardia, arrhythmia or severe heart failure.
  • Inflammatory bowel diseases
  • Chronic diarrhea of known cause.
  • Dementia.
  • Serious illness less than 21 days from the planned entry into the study.
  • Patients treated with medications that have interactions with azithromycin e.g. alkaloids, ciclosporin or amiodarone.
  • Patients involved in the planning or execution of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: azithromycin
azithromycin 500mg
Drug: azithromycin
azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg
Other Names:
  • zitromax
Placebo Comparator: placebo
placebo 500mg
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of diarrhea in days
Time Frame: up to 10 days
up to 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
number of stools/day
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aalborg University Hospital
Slagelse Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

July 4, 2014

Last Update Submitted That Met QC Criteria

July 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number: 2011-000808-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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