Infection Clinical Trial
Official title:
Personalized Immunotherapeutic for Antibiotic-resistant Infection
Verified date | January 2020 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.
Status | Completed |
Enrollment | 1 |
Est. completion date | June 12, 2019 |
Est. primary completion date | June 12, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hosptial | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Silver JN, Ashbaugh CD, Miles JJ, Wu H, Marecki GT, Hwang JK, Jiao JA, Abrams M, Sullivan EJ, Wesemann DR. Deployment of Transchromosomal Bovine for Personalized Antimicrobial Therapy. Clin Infect Dis. 2018 Mar 19;66(7):1116-1119. doi: 10.1093/cid/cix977. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence or absence of mycoplasma hominis cultured from joint and wound fluid | see publication below | from date of initiation of therapy up to 1 year | |
Primary | Patency of fistula as assessed by clinical exam | see publication below | from date of initiation of therapy up to 1 year | |
Primary | Pain reduction as measured by pain scale and amount of pain medication required | see publication below | from date of initiation of therapy up to 1 year |
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