Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled Trial Of Azithromycin In Campylobacter Concisus Positive Patients With Diarrhea
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.


Options:
A: Inclusion Criteria:

* Myeloma diagnosis according to IMWG criteria
* Treatment demanding disease
* High-dose melphalan with stem cell support scheduled as a part of the treatment
* Signed informed consent given prior to any study related activities
* Age \> 18 years

Exclusion Criteria:

* Allogeneic transplantation scheduled as a part of the treatment
* Myeloma treatment prior to entry in the study, except radiotherapy, bisphosphonates/denosumab or corticosteroids for symptom control
* Concurrent disease making clarithromycin treatment unsuitable
* Positive pregnancy test (only applicable for women with childbearing potential)
* Known or suspected hypersensitivity or intolerance to clarithromycin
* Prolonged QT corrected (QTc) interval ( \> 500 msec on screening ECG)
* Concurrent treatment with cabergoline, fluconazole, ketoconazole, pimozide, quetiapine, sirolimus, verapamil, tacrolimus, ergot alkaloid, simvastatin or other statins
* Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, uncontrolled angina or known cardiac amyloidosis
* Severe renal dysfunction (estimated creatinine clearance \<10 mL/min)
* Serious medical or psychiatric illness which, in the judgment of the investigator, would make the patient inappropriate for entry into the study
B: Inclusion Criteria:

* Confirmed COPD diagnosis
* Informed Consent: Patients must give their signed and dated written informed consent to participate
* Gender: Male or female patients
* Age: ≥ 45 years of age at screening
* Produce sputum regularly (produce sputum in at least 3 months of a year)
* Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen.
* Severity of disease: Patients with a measured FEV1\<80% of predicted normal values as determined at screening. An average of three spirometry readings will be taken.

Exclusion Criteria:

* Patients with TB, other chronic respiratory disease (e.g. chronic asthma, bronchiectasis, pulmonary fibrosis), patients with hepatic or renal impairment and patients with prolonged QT interval and other cardiac abnormalities.
* Patients with known hypersensitivity to the antibiotics under evaluation.
* Patients on long term antibiotics for other conditions.
* Patients with uncontrolled hypertension.
* Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
* Patients with a history of long QT syndrome or whose QTc measured at Visit 1 is prolonged (\>450 msec for males and females) as confirmed by the ECG assessor.
* Clinically relevant abnormal laboratory values at the screening assessment that could interfere with the objectives of the trial or safety of the volunteer.
* Patient taking clinically significant contraindicated medication, as per the SmPCs
C: Inclusion Criteria:

Communities:

* The community location in target district.
* The community leader consents to participation in the trial
* The community's estimated population is between 200-2,000 people.
* The community is not in an urban area.

Individuals (Intervention):

- Children-treated arms (all 3 sites): All children aged 1-60 months (up to but not including the 5th birthday), as assessed at the most recent biannual census

Individuals (Examination \& Sample Collection):

* All swabs, blood tests, and stool samples: A random sample of children aged 1-60 months (up to but not including the 5th birthday) based on the previous census
* Anthropometric measurements: All children aged 1-60 months (up to but not including the 5th birthday) will have anthropometric measurements assessed.
* Nasopharyngeal swabs in untreated children: A random sample of individuals aged 7 - 12 years (7th birthday up to but not including the 12th birthday), as assessed from the previous census
* Clinic-based nasopharyngeal swabs: All children aged 1-60 months (up to but not including the 5th birthday) who present to a local health clinic in the study area and report symptoms of a respiratory infection

Exclusion Criteria:

Individuals:

* Pregnant women
* All those who are allergic to macrolides or azalides
* Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
D: 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.

Answer: D