Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

NCT01531218 | Completed Phase 3 DMC

• 1 other identifier: EudraCT number: 2011-000808-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Fever; Vomiting; Abdominal Pain

Keywords

Campylobacter; concisus; diarrhea; fever; abdominal pain; vomiting

Outcome Measures

Primary Outcomes (1)

• Duration of diarrhea in days

  up to 10 days

Secondary Outcomes (1)

• number of stools/day

  one day

Study Arms (2)

azithromycin

ACTIVE COMPARATOR

azithromycin 500mg

Drug: azithromycin

placebo

PLACEBO COMPARATOR

placebo 500mg

Drug: Placebo

Interventions

azithromycin DRUG

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

Also known as: zitromax

azithromycin

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aalborg University Hospital: collaborator
• Slagelse Hospital: collaborator

Study Sites (1)

Department of Infectious Diseases, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27893820 DERIVED

MeSH Terms

Conditions

Diarrhea; Fever; Vomiting; Abdominal Pain

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 10, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 4, 2014

Record last verified: 2014-01

Locations

DK (1)