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Completed

NCT Number: NCT01531218

Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Infectious Diseases, Aalborg Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

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

Other names: zitromax

Placebo

Drug

Primary outcomes

  1. Duration of diarrhea in days

    Time frame: up to 10 days

Secondary outcomes

  1. number of stools/day

    Time frame: one day

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Slagelse Hospital

Registry information

Official study title

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

Acronym: Concisus2012

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 10, 2012
Registry last updated
Jul 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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