Completed

Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma

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What is being tested

interferon gamma

Drug
Who is being recruted

Actinomycetales Infections+4

+ Bacterial Infections and Mycoses

+ Bacterial Infections

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1992
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1992

Actual date on which the first participant was enrolled.

This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.

NCT00001318
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Actinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsInfectionsMycobacterium InfectionsGram-Positive Bacterial InfectionsMycobacterium Infections, Nontuberculous

Criteria

Demonstrated non-tuberculous mycobacterial infection, either disseminated or pulmonary. Received medical treatment for at least 3 months without improvement. Preserved renal, hepatic and hematologic function. Negative pregnancy urine and effective contraceptive. Age range greater than 5. No secondary immunodeficiency such as HIV or malignancy. Not currently receiving cytotoxic therapy within the past 3 months. Not pregnant or lactating. No seizure disorders. No known symptomatic cardiac disease.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, United StatesOpen National Institute of Allergy and Infectious Diseases (NIAID) in Google Maps
CompletedOne Study Center