Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa
Brief Summary: This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.


Options:
A: Inclusion Criteria:

* Pregnant women (aged 18 to 45 years)
* in labour
* attending a health centre in western Gambia for delivery

Exclusion Criteria:

* Known HIV infection.
* Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician.
* Planned travelling out of the catchment area during the following 2 months (follow-up period)
* Planned caesarean section
* Known required referral
* Known multiple pregnancy
* Known severe congenital malformation
* Intrauterine death confirmed before randomization
* Known allergy to macrolides
* Consumption of antibiotic within the week before randomisation
B: Inclusion Criteria:

* Male or female, 6-18 years of age at enrollment
* Confirmed diagnosis of CF
* Written informed consent (and assent when applicable)
* Clinically stable at enrollment as assessed by the site investigator
* FEV1 % predicted \> 50%
* Ability to comply with medication use, study visits, and study procedures
* Ability to swallow a 250 mg tablet

Exclusion Criteria:

* Weight less than 18.0 kg
* Respiratory culture positive for P. aeruginosa, NTM, or B. cepacia complex within 1 year or at screening, or AFB positive at screening
* Allergy to macrolide antibiotics
* Use of macrolide antibiotics (e.g., azithromycin, clarithromycin) within 60 days of screening
* Use of systemic corticosteroids or intravenous or oral antibiotics within 14 days of screening
* Initiation of high dose ibuprofen, Pulmozyme®, hypertonic saline or aerosolized antibiotics within 30 days of screening
* Chronic therapy with drugs known to have rare but serious interactions with azithromycin: amiodarone, digoxin, disopyramide, lovastatin, pimozide, rifabutin, and nelfinavir
* Investigational drug use within 30 days of screening
* Laboratory abnormalities (creatinine, liver function or neutropenia) at screening and confirmed at follow-up testing prior to randomization
* History of biliary cirrhosis, portal hypertension, or splenomegaly, or splenomegaly on physical exam
* History of ventricular arrhythmia
* Other major organ dysfunction, excluding pancreatic dysfunction
* History of lung transplantation or currently on lung transplant list
* Relative decrease in FEV1 % predicted ≥ 20% between the screening and enrollment visit
* Positive serum pregnancy test at screening
* Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study
* History of alcohol, illicit drug or medication abuse within 1 year of screening in the judgment of the site investigator
* Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data
C: Inclusion Criteria:RA according to the 1987 American Rheumatism Association criteria19, age between 18 and 70 years. Patients were required to have had an inadequate response to one to four DMARDs (such as azathioprine, methotrexate, sulfasalazine, penicillamine, hydroxychloroquine, or oral or injectable gold); an inadequate response was defined as discontinuation of therapy because of lack of effect. If patients were receiving DMARDs, they were required to complete a DMARD washout period that lasted at least 1 month before starting study drug treatment; no DMARDs were permitted during the study. Patients who were receiving nonsteroidal antiinflammatory drugs, prednisone (at 10 mg daily or less), or both were eligible if the doses had been stable for at least four weeks before the study period and continued to be stable during the study period. Patients were not allowed to receive intra-articular corticosteroids.

Patients had to have active disease at enrollment (before the DMARD washout period), defined as 12 or more tender joints, 10 or more swollen joints, and at least one of the following: erythrocyte sedimentation rate(ESR) of at least 28 mm/hr, C-reactive protein(CRP) level greater than 2.0 mg/dL, or morning stiffness for at least 45 minutes.

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Exclusion Criteria:

* A negative pregnancy test result was required for non-menopausal female patients. In female patients of childbearing potential a urine pregnancy test was done at baseline and any pregnant women were excluded. Other exclusion criteria included impaired hepatic enzyme tests, impaired renal function, chronic/recurrent infection (e.g., chronic bronchitis, recurrent sinusitis), other infections(e.g., Borrelia burgdorferi, Chlamydia trachomatis, Ureaplasma) , history of adverse reactions to macrolides, roxithromycin, or similar antibiotics.

A patient could be withdrawn from the trial at any time after enrollment for the following reasons: the patient's request, severe or life-threatening adverse event, or inadequate control of arthritis symptoms (\>50 percent increase in the total number of swollen or tender joints) necessitating an increase in the systemic corticosteroid dosage or reinstitution of therapy with disease-modifying antirheumatic drugs.
D: 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

Answer: B