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

Primary Purpose

Diarrhea, Fever, Vomiting

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
azithromycin
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Campylobacter, concisus, diarrhea, fever, abdominal pain, vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Infectious Diseases, Aalborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

azithromycin

placebo

Arm Description

azithromycin 500mg

placebo 500mg

Outcomes

Primary Outcome Measures

Duration of diarrhea in days

Secondary Outcome Measures

number of stools/day

Full Information

First Posted
February 8, 2012
Last Updated
July 3, 2014
Sponsor
University of Aarhus
Collaborators
Aalborg University Hospital, Slagelse Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01531218
Brief Title
Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea
Acronym
Concisus2012
Official Title
Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aalborg University Hospital, Slagelse Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Fever, Vomiting, Abdominal Pain
Keywords
Campylobacter, concisus, diarrhea, fever, abdominal pain, vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
azithromycin
Arm Type
Active Comparator
Arm Description
azithromycin 500mg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo 500mg
Intervention Type
Drug
Intervention Name(s)
azithromycin
Other Intervention Name(s)
zitromax
Intervention Description
azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Duration of diarrhea in days
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
number of stools/day
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Infectious Diseases, Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27893820
Citation
Nielsen HL, Kirk KF, Bodilsen J, Ejlertsen T, Nielsen H. Azithromycin vs. Placebo for the Clinical Outcome in Campylobacter concisus Diarrhoea in Adults: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. PLoS One. 2016 Nov 28;11(11):e0166395. doi: 10.1371/journal.pone.0166395. eCollection 2016.
Results Reference
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Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

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