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NCT00001407 · ClinicalTrials.gov registry record · Phase 2
Interferon Gamma for Drug Resistant Tuberculosis
A Phase 2 study of Pneumonia and Pulmonary Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00001407 is a Phase 2 study of Pneumonia and Pulmonary Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 4,519-participant average among 47 other Pneumonia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001407, a Phase 2 study of Pneumonia and Pulmonary Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine what dose of recombinant interferon-gamma is safe and effective for treating multiple drug-resistant tuberculosis. Recombinant interferon-gamma is a genetically engineered form of a substance normally produced by the body and is used to boost immune function. Patients 5 years of age and older with multiply drug-resistant tuberculosis may be eligible for this study. Participants will be admitted to either the NIH Clinical Center in Bethesda, Maryland, the Texas Center for Infectious Diseases in San Antonio or the South Texas Hospital or Valley Baptist Hospital, both in Harlingen, Texas. On admission, patients will have a medical history, physical examination, blood and urine tests, sputum culture, X-rays, pulmonary function tests and a computed tomography (CT) scan. CT produces 3-dimensional images of body tissues and organs in small sections. For the procedure, the patient lies still on a table surrounded by the scanner. All patients will continue treatment with anti-tuberculosis antibiotics during and after the study period and may elect whether or not to take gamma interferon in addition to the antibiotic. Five patients will receive only antibiotic treatment, and 5 each will receive one of 3 doses (0.025, 0.05 or 0.1 milligrams per square meter of body surface area) of interferon-gamma injected under the skin 3 times a week. The patient or caregiver will be taught to give the injections, which are similar to insulin injections for diabetes. Patients will be in isolation in the hospital from the start of therapy until sputum samples show no evidence of tuberculosis for 3 consecutive weeks. Following that, they will repeat the tests done on admission (except CT) during follow-up visits (1- to 2-day hospitalizations) at 3, 6, 9, 12, 15, 18 and 24 months after the start of therapy. Patients taking interferon gamma will have blood drawn more frequently (monthly) for the first 6 months, and patients with lung infection will have sputum samp
Conditions Studied
Interventions
- DRUG Interferon Gamma
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1994-05 |
| Est. Completion | 2003-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001407
The ClinicalTrials.gov registry entry for NCT00001407 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,519-participant average among 47 other Pneumonia trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pneumonia appearing as the primary indexed condition, and to 1 intervention - of which Interferon Gamma is the first listed.
NCT00001407 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001407 about?
NCT00001407 is a clinical study titled "Interferon Gamma for Drug Resistant Tuberculosis". This study will determine what dose of recombinant interferon-gamma is safe and effective for treating multiple drug-resistant tuberculosis. Recombinant interferon-gamma is a genetically engineered form of a substance normally produced by the body and is used to boost immune function. Patients 5 ye...
What is the current status of trial NCT00001407?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 1994-05. Estimated completion is 2003-05.
What conditions does trial NCT00001407 study?
This clinical trial studies the following conditions: Pneumonia, Pulmonary Tuberculosis.
What interventions are being tested in trial NCT00001407?
The interventions under investigation include: Interferon Gamma (DRUG).
Who is sponsoring clinical trial NCT00001407?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001407 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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