Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy
NCT ID: NCT01379196
Last Updated: 2017-04-27
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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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2011-05-31
2014-12-31
Brief Summary
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Indices for follow-up will include:
* Clinical activity score
* Anti-TSH receptor antibody levels
* Thickening of extraocular muscles per ultrasound
* Quality of life score for Graves Orbitopathy patients
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Detailed Description
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Treatment of inflammatory stage moderate-severe GO includes steroids, as recommended by the EUGOGO consortium. However, the length of treatment needed and the risk of steroid side-effects may lead to multiple undesired treatment induced morbidity.
Antibiotics of the macrolide group posses known immune-modulatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of macrolide antibiotics for delaying graft rejection following lung transplants.
We propose to test the effect of this class of antibiotics for non-sight threatening, moderate-severe, inflammatory GO.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Azithromycin PO three times weekly
Tablets Azithromycin 500 mg PO three times weekly for three months
Azithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Interventions
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Azithromycin
Tab. Azithromycin 500 mg PO three times weekly for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical activity score higher than 2
* Must be able to swallow tablets
Exclusion Criteria
* Diplopia in primary gaze
* Macrolide allergy or intolerance
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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kalish hadas
Chief, Neuro-Ophthalmology Unit
Principal Investigators
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Hadas Kalish, MD
Role: PRINCIPAL_INVESTIGATOR
Neuro-Ophthalmology Unit, Rabin Medical Center, Petah Tikva 49100 Israel
Other Identifiers
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0427-10-RMC
Identifier Type: -
Identifier Source: org_study_id
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