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

This study has been completed.
Sponsor:
Collaborators:
Aalborg Universityhospital
Slagelse Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01531218
First received: February 8, 2012
Last updated: July 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Diarrhea
Fever
Vomiting
Abdominal Pain
Drug: azithromycin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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 ]

Enrollment: 100
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: azithromycin
azithromycin 500mg
Drug: azithromycin
azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg
Other Name: zitromax
Placebo Comparator: placebo
placebo 500mg
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531218

Locations
Denmark
Department of Infectious Diseases, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Aalborg Universityhospital
Slagelse Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01531218     History of Changes
Other Study ID Numbers: EudraCT number: 2011-000808-18
Study First Received: February 8, 2012
Last Updated: July 3, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Campylobacter
concisus
diarrhea
fever
abdominal pain
vomiting

Additional relevant MeSH terms:
Abdominal Pain
Diarrhea
Fever
Vomiting
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Body Temperature Changes
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014