Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

Diarrhea Clinical Trial

— Concisus2012  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531218
• Other study ID #: EudraCT number: 2011-000808-18
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2012
• Last updated: July 3, 2014
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Diarrhea
• Fever
• Vomiting

Intervention

Drug:
• azithromycin
azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg
• Placebo

Locations

Country	Name	City	State
Denmark	Department of Infectious Diseases, Aalborg Hospital	Aalborg

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Universitetshospital, Slagelse Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of diarrhea in days		up to 10 days	No
Secondary	number of stools/day		one day	No