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NCT02508584 · ClinicalTrials.gov registry record · Early Phase 1

Personalized Immunotherapeutic for Antibiotic-resistant Infection

A Early Phase 1 study of Infection and Immune Deficiency, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Early Phase 1
Development phase
1
Enrollment target
1
Study location

NCT02508584: Completed Early Phase 1 study of Infection and Immune Deficiency, sponsored by Brigham and Women's Hospital.

NCT02508584 is a Early Phase 1 study of Infection and Immune Deficiency that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 1 participants, below the 726-participant average among 41 other Infection trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02508584, a Early Phase 1 study of Infection and Immune Deficiency, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Early Phase 1
Development phase
1 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

see publication below

Conditions Studied

Infection Immune Deficiency Septic Arthritis Hypogammaglobulinemia Mycoplasma Hominis

Interventions

  • BIOLOGICAL anti-mycoplasma hominis antibodies

Study Locations (1)

Massachusetts

  • Brigham and Women's Hosptial - Boston

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2016-04-12
Est. Completion 2019-06-12
Phase Early Phase 1
Brigham and Women's Hospital

937 total trials

What the finished NCT02508584 record still lists

NCT02508584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 726-participant average among 41 other Infection trials with a reported enrollment target (100% lower).

The record links to 5 conditions, with Infection appearing as the primary indexed condition, and to 1 intervention - of which anti-mycoplasma hominis antibodies is the first listed.

NCT02508584 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02508584 about?

NCT02508584 is a clinical study titled "Personalized Immunotherapeutic for Antibiotic-resistant Infection". 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 r...

What is the current status of trial NCT02508584?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2016-04-12. Estimated completion is 2019-06-12.

What conditions does trial NCT02508584 study?

This clinical trial studies the following conditions: Infection, Immune Deficiency, Septic Arthritis, Hypogammaglobulinemia, Mycoplasma Hominis.

What interventions are being tested in trial NCT02508584?

The interventions under investigation include: anti-mycoplasma hominis antibodies (BIOLOGICAL).

Who is sponsoring clinical trial NCT02508584?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02508584 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02508584's enrollment target sits among peer trials

1 42nd of 41 the lowest of 41 other Infection trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02508584, the US trial registry maintained by the National Library of Medicine. NCT02508584 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.