Clinical trial: Azithromycin a Treatment for Pulmonary Sarcoidosis (NCT04020380)

Eligibility criteria:
Inclusion Criteria:

          -  • Males or females, of any race, between 18 and 80 years of age, inclusive;

               -  Able to speak, read, and understand English;

               -  Able to provide written informed consent;

               -  Able to communicate effectively with the Investigator and other study centre
                  personnel and agree to comply with the study procedures and restrictions.

               -  Clinician diagnosis of pulmonary sarcoidosis;

               -  If a female of child-bearing potential (i.e., have not undergone a hysterectomy
                  or bilateral oophorectomy) or not post-menopausal (defined as no menses for at
                  least 12 months), agree to use acceptable birth control (defined in Section 6.3)
                  from screening through to the follow up visit;

        Exclusion Criteria:

          -  • Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin,
             clarithromycin) or excipients (see 7.4)

               -  History of signficant cardiac arrhythmia

               -  Personal or family history of congenital long QT syndrome;

               -  Prolonged QTc interval on 12-lead ECG

               -  Signficant liver disease

               -  Evidence of acute bacterial infection

               -  Clinically significant bronchiectasis

               -  Requiring concomitant therapy with prohibited medications (see Section 7.5)

               -  Pregnant or breastfeeding;

               -  Treatment with an investigational drug or biologic within 30 days preceding the
                  first dose of study medication or plans to take another investigational drug or
                  biologic within 30 days of study completion;

               -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
                  abnormality that may increase the risk associated with trial participation or
                  investigational product administration or may interfere with the interpretation
                  of trial results and, in the judgment of the Investigator or Sponsor, would make
                  the subject inappropriate for entry into this trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs.  She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications.  On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli.

Patient description (patient's own words): I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB.

Does the patient match the trial criteria? Entailment