Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea (Concisus2012)
This study has been completed.
Information provided by (Responsible Party):
University of Aarhus
First received: February 8, 2012
Last updated: July 3, 2014
Last verified: January 2014
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea
Primary Outcome Measures:
- Duration of diarrhea in days [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- number of stools/day [ Time Frame: one day ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Active Comparator: azithromycin
azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg
Other Name: zitromax
Placebo Comparator: placebo
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01531218
|Department of Infectious Diseases, Aalborg Hospital
|Aalborg, Denmark, 9000 |
University of Aarhus
No publications provided
||University of Aarhus
History of Changes
|Other Study ID Numbers:
||EudraCT number: 2011-000808-18
|Study First Received:
||February 8, 2012
||July 3, 2014
||Denmark: The Regional Committee on Biomedical Research Ethics
Keywords provided by University of Aarhus:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 03, 2015
Signs and Symptoms
Signs and Symptoms, Digestive