DiarrheaPhase 3Concisus2012NCT01531218
Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea
A Phase 3 study testing azithromycin in people with Diarrhea and Fever, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Infectious Diseases, Aalborg Hospital
Aalborg, 9000
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive 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.
- Conditions
- Diarrhea, Fever, Vomiting, Abdominal Pain
- Being tested
- azithromycin, Placebo
- Keywords
- Campylobacter, concisus, diarrhea, fever, abdominal pain, vomiting
- Medical subject headings
- Diarrhea, Fever, Vomiting, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
Also called zitromax
azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| azithromycin | Active comparator | azithromycin 500mg Receives: Drug: azithromycin |
| placebo | Placebo comparator | placebo 500mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea in days
Measured: up to 10 days
Secondary outcomes (1)
number of stools/day
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Slagelse Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531218
- Sponsor's protocol ID
- EudraCT number: 2011-000808-18
- Acronym
- Concisus2012
- Status last verified
- Jan 2014
- First submitted
- 8 Feb 2012
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27893820
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea
- ClinicalTrials.gov ID
- NCT01531218
- Acronym / sponsor ID
- Concisus2012 / EudraCT number: 2011-000808-18
- Conditions
- Diarrhea, Fever, Vomiting, Abdominal Pain
- Keywords
- Campylobacter, concisus, diarrhea, fever, abdominal pain, vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Slagelse Hospital
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azithromycin | Active comparator | Drug: azithromycinazithromycin 500mg |
| placebo | Placebo comparator | Drug: Placeboplacebo 500mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azithromycinAlso: zitromaxazithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg | Drug | azithromycin |
| Placebo | Drug | placebo |
Primary outcome
Duration of diarrhea in days
Time frame: up to 10 days
1 secondary outcome
number of stools/day
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- Derived from this study: PubMed 27893820Nielsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azithromycin in people with Diarrhea and Fever, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of diarrhea in days (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2014.