Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea (Concisus2012)
This study is currently recruiting participants.
Verified October 2012 by University of Aarhus
Sponsor:
University of Aarhus
Collaborators:
Aalborg Universityhospital
Slagelse Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01531218
First received: February 8, 2012
Last updated: October 29, 2012
Last verified: October 2012
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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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | February 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 | 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531218
Contacts
| Contact: Hans L Nielsen, MD. | +45 99 32 65 32 | halin@rn.dk |
| Contact: Henrik Nielsen, Prof. MD. |
Locations
| Denmark | |
| Department of Infectious Diseases, Aalborg Hospital | Recruiting |
| Aalborg, Denmark, 9000 | |
| Contact: Hans L Nielsen, MD. +45 99 32 65 32 halin@rn.dk | |
| Contact: Henrik Nielsen, Prof. MD. | |
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: | October 29, 2012 |
| 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 May 22, 2013