Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
Conditions Studied
Interventions
- BIOLOGICAL anti-mycoplasma hominis antibodies
Study Locations (1)
Massachusetts
- Brigham and Women's Hosptial - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-04-12 |
| Est. Completion | 2019-06-12 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02508584
The ClinicalTrials.gov registry entry for NCT02508584 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 726-participant average among 41 other Infection trials with a reported enrollment target (100% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Infection
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.
-
Home Hospital for Suddenly Ill Adults
RECRUITING · NA
-
Copper Supplementation in Cirrhosis
RECRUITING · NA
-
Persona Revision Knee System Outcomes
RECRUITING
-
NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
RECRUITING · Phase 1
-
Diagnosis and Management of Inflammatory and Infectious Diseases
RECRUITING
-
BLOOM: Pragmatic Feasibility Trial
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.