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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01531218
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : July 4, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Diarrhea Fever Vomiting Abdominal Pain Drug: azithromycin Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea
Study Start Date : March 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

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 Name: zitromax
Placebo Comparator: placebo
placebo 500mg
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Duration of diarrhea in days [ Time Frame: up to 10 days ]

Secondary Outcome Measures :
  1. number of stools/day [ Time Frame: one day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531218


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01531218     History of Changes
Other Study ID Numbers: EudraCT number: 2011-000808-18
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: July 4, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Diarrhea
Vomiting
Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases