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The PHENOSAR trial: Antibiotic treatment of biopsy confirmed phenotypes in sarcoidosis: a proof of concept clinical trial

The PHENOSAR trial: Antibiotic treatment of biopsy confirmed phenotypes in sarcoidosis: a proof of concept clinical trial - The PHENOSAR trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56424
Enrollment
40
Registered
2022-08-10
Start date
2023-03-23
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoidosis

Interventions

The study population will be divided into two groups receiving either Doxycycline and Azithromycin or placebo for 3 months. Both groups will contain an equal amount of patient in which C. acnes can

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Biopsy proven sarcoidosis. No treatment indication for the sarcoidosis in case of treatment, started at least 12 months ago. with stable dosis and no intention of changing this treatment during this study Inflammatory activity according to FDG-PET scan SUVmax above 3 in lungs and above 5 in mediastinum/hili

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The difference in inflammatory activation based on blood biomarkers and FDG-PET of patients which were treated with Doxycyclin and Azithormycin compared to patients treated with placebo

Secondary

MeasureTime frame
Measure the presence of C.acnes in biopsies Measure the activity of the signaling pathways in biopsies

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)