the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis

NCT05291468 | Active Not Recruiting

• 1 other identifier: NL73729.100.21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoidosis, Pulmonary; Sarcoidosis Skin

Keywords

Cutibacterium acnes; antibiotics; azithromycin; doxycycline

Outcome Measures

Primary Outcomes (1)

• SUVmax

  Difference of standarized uptake value (SUVmax) uptake after treatment with antibiotics between patients with and without C. acnes in their granuloma

  2 weeks

Secondary Outcomes (2)

• lung function

  2 weeks

• quality of life according to questionnaire

  2 weeks

Other Outcomes (2)

• serum biomarker: ACE

  2 weeks

• serum biomarker: IL-2R

  2 weeks

Study Arms (4)

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

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

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

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

Radiation: FDG-PET/CT

Interventions

FDG-PET/CT RADIATION

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.

Also known as: serum biomarkers, additional skin biopsy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist, Principle Investigator, member of staff ILD Center of Excllence

Model Details: 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

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 22, 2022
• Study Start: February 15, 2023
• Primary Completion: April 26, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)