the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis

Status Not yet recruiting

Clinical Trial Summary

In this study it is investigated whether treatment with azithromycin in combination with doxycycline reduces the bacterial load of C. acnes in granulomatous tissue of patients with sarcoidosis and subsequently decreases the inflammatory activation measured by FDG uptake and serum biomarkers.

Clinical Trial Description

Sarcoidosis is a multisystemic disease with unknown origin mostly affecting intrathoracic lymph nodes, lungs and skin. Sarcoidosis is characterized by the formation of non-caseating granulomas causing a variety of symptoms based on the organs involved. Although frequently described as a benign disease, mortality rate has been estimated to be around 11.0 per 1000 person-years in patients with sarcoidosis, with respiratory failure as the most common cause of death in the western world. The main treatment indication in sarcoidosis is risk of organ failure. In the literature the need for systemic treatment varies between 20-70%. Since there is no curative treatment for sarcoidosis, treatment is focused on suppression of the inflammation. This is usually done with the use of immunosuppressive drugs, such as prednisone and/or methotrexate, and in patients with severe refractory disease infliximab. It is well known that treatment with immunosuppressive drugs is associated with burdensome side effects for patients and impaired quality of life. Considerable research has been done on the possible role C. acnes in the pathogenesis of sarcoidosis. In a recent work of our own group it was shown that presence of C. acnes within granulomatous tissue can be detected in 41% of Dutch patients with sarcoidosis. Azithromycin has an inhibiting effect on several bacterial infections, such as C. acnes. Therefore, sarcoidosis patients with C. acnes in the granulomatous tissue might benefit from treatment with azithromycin. Given the fact that microbial resistance to azithromycin is relatively easy to develop, it is common practice to treat C. acnes with a combination of azithromycin and doxycycline. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05291468
Study type	Interventional
Source	St. Antonius Hospital
Contact	Marcel Veltkamp, Dr.
Phone	+31883201425
Email	m.veltkamp@antoniusziekenhuis.nl
Status	Not yet recruiting
Phase	N/A
Start date	January 1, 2023
Completion date	June 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04020380` - Azithromycin a Treatment for Pulmonary Sarcoidosis	Phase 2
Recruiting	`NCT03260556` - Pirfenidone for Progressive Fibrotic Sarcoidosis	Phase 4
Completed	`NCT05759221` - Peripheral Airway Biopsy in Sarcoidosis	N/A
Completed	`NCT03336736` - The Role of Physical Activity and Diet Within Pulmonary Sarcoidosis
Completed	`NCT03140644` - SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis	N/A
Completed	`NCT03793439` - Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis	Phase 1
Recruiting	`NCT04895111` - Endobronchial Ultrasound Strain Elastography in Sarcoidosis
Not yet recruiting	`NCT05910554` - Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis	Phase 2
Recruiting	`NCT05374447` - Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy	N/A
Active, not recruiting	`NCT04314193` - Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis	Phase 4
Completed	`NCT03727451` - A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis	Phase 2
Recruiting	`NCT05746039` - Feasibility of Semaglutide in Advanced Lung Disease	Phase 1/Phase 2
Completed	`NCT04803617` - Investigation of Pectoralis Muscle Strength in Elderly With Interstitial Lung Disease
Recruiting	`NCT03145922` - Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis
Completed	`NCT00279708` - Atorvastatin to Treat Pulmonary Sarcoidosis	Phase 2
Recruiting	`NCT05567133` - Risk Indicators of Sarcoidosis Evolution-Unified Protocol
Completed	`NCT05311150` - An RCT of NBI vs. White Light Guided Endobronchial Biopsy in Suspected Sarcoidosis	N/A
Completed	`NCT05811962` - The Diagnostic and Prognostic Role of SAA in Intrathoracic Sarcoidosis
Completed	`NCT03320070` - Acthar Gel in Participants With Pulmonary Sarcoidosis	Phase 4
Completed	`NCT03324503` - A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.