Status:
UNKNOWN
the PHENOSAR Trial: Use of Antibiotics in Treatment of Sarcoidosis
Lead Sponsor:
St. Antonius Hospital
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Sarcoidosis, Pulmonary
Sarcoidosis Skin
Eligibility:
All Genders
18+ years
Phase:
NA
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 sub...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05291468
Start Date
January 1 2023
End Date
June 30 2023
Last Update
December 13 2022
Active Locations (1)
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1
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM