Sarcoidosis, PulmonaryNCT05291468
the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis
A study testing FDG-PET/CT in people with Sarcoidosis, Pulmonary and Sarcoidosis Skin, run by St. Antonius Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary, Sarcoidosis Skin
- What is being tested?
- FDG-PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Feb 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven sarcoidosis.
- 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
Who cannot join
- Increased duration of QT interval (>440ms for men and >450ms for women) on ECG
- Hearing deficits, as this is a possible side effect of azithromycin
- Being pregnant or breastfeeding at time of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHENOtype Based Therapy With Antibiotics in SARcoidosis Patients With and Without Presence of Cutibacterium Acnes in Granulomatous Tissue
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.
Read the 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.
- Conditions
- Sarcoidosis, Pulmonary, Sarcoidosis Skin
- Being tested
- FDG-PET/CT
- Keywords
- Cutibacterium acnes, antibiotics, azithromycin, doxycycline
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET/CTRadiation
Also called serum biomarkers, additional skin biopsy
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.
| Study group | Role | What they receive |
|---|---|---|
| C Acnes present in granulomatous tissue, treatment with antibiotics | Active comparator | patients who are in this arm will receive azithromycin and doxycycline for 3 months Receives: Radiation: FDG-PET/CT |
| C Acnes present in granulomatous tissue, treatment with placebo | Placebo comparator | patients who are in this arm will receive placebo for 3 months Receives: Radiation: FDG-PET/CT |
| C Acnes NOT present in granulomatous tissue, treatment with antibiotics | Active comparator | patients who are in this arm will receive azithromycin and doxycycline for 3 months Receives: Radiation: FDG-PET/CT |
| C. Acnes NOT present in granulomatous tissue, treatment with placebo | Placebo comparator | patients who are in this arm will receive placebo for 3 months Receives: Radiation: FDG-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
Difference of standarized uptake value (SUVmax) uptake after treatment with antibiotics between patients with and without C. acnes in their granuloma
Measured: 2 weeks
Secondary outcomes (2)
lung function
Difference in FVC after treatment with antibiotics between patients with and without C. acnes in their granulomatous tissue
Measured: 2 weeks
quality of life according to questionnaire
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Feb 2023
- Primary completion26 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study population will be divided in 4 groups Group A consists of patients with C. Acnes present in their tissue Group B consists of patients without C. Acnes present in their tissue 50% of patients in each group will be treated with antibiotics and 50% with placebo. Study duration is 4 months
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Marcel Veltkamp, MD,PhD, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291468
- Sponsor's protocol ID
- NL73729.100.21
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data of patients will be coded and will not be traceable to a specific participant when used by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHENOtype Based Therapy With Antibiotics in SARcoidosis Patients With and Without Presence of Cutibacterium Acnes in Granulomatous Tissue
- ClinicalTrials.gov ID
- NCT05291468
- Acronym / sponsor ID
- NL73729.100.21
- Conditions
- Sarcoidosis, Pulmonary, Sarcoidosis Skin
- Keywords
- Cutibacterium acnes, antibiotics, azithromycin, doxycycline
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- The study population will be divided in 4 groups Group A consists of patients with C. Acnes present in their tissue Group B consists of patients without C. Acnes present in their tissue 50% of patients in each group will be treated with antibiotics and 50% with placebo. Study duration is 4 months
| Arm | Type | Receives |
|---|---|---|
| C Acnes present in granulomatous tissue, treatment with antibiotics | Active comparator | Radiation: FDG-PET/CTpatients who are in this arm will receive azithromycin and doxycycline for 3 months |
| C Acnes present in granulomatous tissue, treatment with placebo | Placebo comparator | Radiation: FDG-PET/CTpatients who are in this arm will receive placebo for 3 months |
| C Acnes NOT present in granulomatous tissue, treatment with antibiotics | Active comparator | Radiation: FDG-PET/CTpatients who are in this arm will receive azithromycin and doxycycline for 3 months |
| C. Acnes NOT present in granulomatous tissue, treatment with placebo | Placebo comparator | Radiation: FDG-PET/CTpatients who are in this arm will receive placebo for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy proven sarcoidosis.
- 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
Key exclusion criteria (3 listed)
- Increased duration of QT interval (>440ms for men and >450ms for women) on ECG
- Hearing deficits, as this is a possible side effect of azithromycin
- Being pregnant or breastfeeding at time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PET/CTAlso: serum biomarkers, additional skin biopsyPatients 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. | Radiation | C Acnes NOT present in granulomatous tissue, treatment with antibiotics, C Acnes present in granulomatous tissue, treatment with antibiotics, C Acnes present in granulomatous tissue, treatment with placebo, C. Acnes NOT present in granulomatous tissue, treatment with placebo |
Primary outcome
SUVmax
Time frame: 2 weeks
Difference of standarized uptake value (SUVmax) uptake after treatment with antibiotics between patients with and without C. acnes in their granuloma
2 secondary outcomes
lung function
Time frame: 2 weeks
quality of life according to questionnaire
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. data of patients will be coded and will not be traceable to a specific participant when used by other researchers
Related trials for Sarcoidosis, Pulmonary
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
Not yet recruitingPhase 2
LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Sarcoidosis Associated Pulmonary Hypertension
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
Sarcoidosis, Pulmonary
Not yet recruitingPhase 2
A Clinical Trial of Tulisokibart (MK-7240) in Participants With Pulmonary Sarcoidosis (MK-7240-016)
Pulmonary Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG-PET/CT in people with Sarcoidosis, Pulmonary and Sarcoidosis Skin, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.