Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

Study Overview
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Brief Summary
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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.

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

Conditions
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Diarrhea, Fever, Vomiting, Abdominal Pain

Intervention / Treatment
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* Drug: azithromycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: azithromycin<br>azithromycin 500mg | Drug: azithromycin<br>* azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg<br>* Other names: zitromax;|
| Placebo Comparator: placebo<br>placebo 500mg | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea in days |  | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of stools/day |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Campylobacter, concisus, diarrhea, fever, abdominal pain, vomiting