Phenosar

Phase 4

Not yet recruiting

Conditions: sarcoidosis

Registration Number: 2024-513534-38-00

Lead Sponsor: Sint Antonius Ziekenhuis Stichting

Brief Summary: - Investigate whether treatment with azithromycin and doxycycline results in a reduction of the inflammatory activity defined by SUVmax in patients with sarcoidosis

- Investigate whether treatment of C. acnes related sarcoidosis, defined by presence of C. acnes within and around granulomas, with a combination of azithromycin and doxycycline will lead to a significant decrease of inflammatory activity defined by SUVmax.

Detailed 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.

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Biopsy proven sarcoidosis.
Inflammatory activity according to FDG-PET scan at baseline
SUVmax above 3 in the lung and/or above 5 in mediastinum/hili
No treatment indication for the sarcoidosis

Exclusion Criteria

Increased duration of QT interval (>440ms for men and >450ms for women) on ECG
Hearing deficits, a possible side-effect of azithromycin use is hearing deficits, although the chance of this is very small
Being pregnant or breastfeeding at time of inclusion
Use of an investigational drug during the time between FDG-PET scan and screening.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of sarcoidosis related inflammation.		Reduction of sarcoidosis related inflammation.

Secondary Outcome Measures

Name	Time	Method
lung function	2 weeks	Difference in FVC after treatment with antibiotics between patients with and without C. acnes in their granulomatous tissue
quality of life according to questionnaire	2 weeks	Monitor quality of life for patients treated with antibiotics compared to patients receiving placebo, measured by King's Sarcoidosis Questionnaire that is taken at baseline and end of study. QOL is measured with the King's Sarcoidosis Questionnaire (KSQ), which is a validated questionnare on sarcoidosis with 5 scales and 29 items.

Trial Locations

Locations (1): Sint Antonius Ziekenhuis Stichting
🇳🇱
Nieuwegein, Netherlands
Sint Antonius Ziekenhuis Stichting
🇳🇱Nieuwegein, Netherlands
Montse Janssen Bonas
Site contact
0883201484
m.janssenbonas@antoniusziekenhuis.nl