the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis
NCT ID: NCT05291468
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-01-01
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Study duration is 4 months
TREATMENT
TRIPLE
Study Groups
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C Acnes present in granulomatous tissue, treatment with antibiotics
patients who are in this arm will receive azithromycin and doxycycline for 3 months
FDG-PET/CT
Patients will be randomized in a 1:1 ratio to either receive a combination of doxycycline and azithromycin or placebo during 3 months, after which the inflammatory state of disease is measured by FDG-PET/CT and serum biomarkers. If patients have cutaneous sarcoidosis, a skin biopsy will be performed at baseline and at the end of the study.
C Acnes present in granulomatous tissue, treatment with placebo
patients who are in this arm will receive placebo for 3 months
FDG-PET/CT
Patients will be randomized in a 1:1 ratio to either receive a combination of doxycycline and azithromycin or placebo during 3 months, after which the inflammatory state of disease is measured by FDG-PET/CT and serum biomarkers. If patients have cutaneous sarcoidosis, a skin biopsy will be performed at baseline and at the end of the study.
C Acnes NOT present in granulomatous tissue, treatment with antibiotics
patients who are in this arm will receive azithromycin and doxycycline for 3 months
FDG-PET/CT
Patients will be randomized in a 1:1 ratio to either receive a combination of doxycycline and azithromycin or placebo during 3 months, after which the inflammatory state of disease is measured by FDG-PET/CT and serum biomarkers. If patients have cutaneous sarcoidosis, a skin biopsy will be performed at baseline and at the end of the study.
C. Acnes NOT present in granulomatous tissue, treatment with placebo
patients who are in this arm will receive placebo for 3 months
FDG-PET/CT
Patients will be randomized in a 1:1 ratio to either receive a combination of doxycycline and azithromycin or placebo during 3 months, after which the inflammatory state of disease is measured by FDG-PET/CT and serum biomarkers. If patients have cutaneous sarcoidosis, a skin biopsy will be performed at baseline and at the end of the study.
Interventions
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FDG-PET/CT
Patients will be randomized in a 1:1 ratio to either receive a combination of doxycycline and azithromycin or placebo during 3 months, after which the inflammatory state of disease is measured by FDG-PET/CT and serum biomarkers. If patients have cutaneous sarcoidosis, a skin biopsy will be performed at baseline and at the end of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No treatment indication for the sarcoidosis
* Inflammatory activity according to FDG-PET scan at baseline
* SUVmax above 3 in the lung and/or above 5 in mediastinum/hili
Exclusion Criteria
* Hearing deficits, as this is a possible side effect of azithromycin
* Being pregnant or breastfeeding at time of inclusion
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
St. Antonius Hospital
OTHER
Responsible Party
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Marcel Veltkamp, MD,PhD
Pulmonologist, Principle Investigator, member of staff ILD Center of Excllence
Locations
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St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Marcel Veltkamp, Dr.
Role: primary
Raisa Kraaijvanger, MSc
Role: backup
Other Identifiers
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NL73729.100.21
Identifier Type: -
Identifier Source: org_study_id