A clinical trial of the antibiotic azithromycin for patients with sarcoidosis

Phase 1

• Conditions: Sarcoidosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-000580-24-GB
• Lead Sponsor: Hull & East Yorkshire Hospitals NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Males or females, of any race, between 18 and 80 years of age, inclusive;
2. Able to speak, read, and understand English;
3.Able to provide written informed consent;
4.Able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions.
5.Clinician diagnosis of pulmonary sarcoidosis;
6.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;

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin, clarithromycin) or excipients
2.History of signficant cardiac arrhythmia
3.Personal or family history of congenital long QT syndrome;
4.Prolonged QTc interval on 12–lead ECG
5.Severe liver disease
6.Evidence of acute bacterial infection
7.Clinically significant bronchiectasis
8.Requiring concomitant therapy with prohibited medications (see Section 7.5)
9.Pregnant or breastfeeding;
10.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;
11.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified