Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021567
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-07-24
Brief Title:
A Randomized Double-Blinded Placebo-Controlled Phase II Inhaled Interferon Gamma-1b and Antimycobacterials to Treat Pulmonary Mycobacterium Avium Complex Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Phase II Study of the Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterial in Previously Treated or Moderate to Severe Pulmonary Mycobacterium Avium Complex MAC Infection
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the safety and effectiveness of inhaled interferon gamma-1b and oral antibiotics for treating mycobacterium avium complex MAC infection of the lungs
Patients 18 years of age or older with MAC infection of the lungs who 1 have been previously treated for MAC or 2 have moderate or severe lung disease due to MAC that has not been previously treated may be eligible for this study
Participants will be randomly assigned to one of two treatment groups Group 1 will receive 500 micrograms of interferon gamma-1b 3 times a week for 48 weeks by inhalation Group 2 will inhale a placebo inactive substance according to the same regimen In addition all patients will receive standard MAC treatment with three antibiotics-clarithromycin or azithromycin ethambutol and rifampin or rifabutin-taken by mouth times a week
Patients will come to the clinic for a screening visit baseline visit 1 month after beginning treatment and at 3-month intervals thereafter until the end of the study During these various visits they will undergo the following tests and procedures
Medical history and physical examination including height and weight measurements heart rate breathing rate blood pressure and temperature
Possibly computed tomography CT and X-ray of the lungs
Sputum sample
Pulmonary function studies
Blood and urine tests
Patients eyes will be examined monthly to check for side effects of ethambutol and hearing and balance will be tested to check for side effects of clarithromycin or azithromycin
At the baseline visit the patient or caretaker will be trained to use a nebulizer a special breathing device to take the study medication
Patients 18 years of age or older with MAC infection of the lungs who 1 have been previously treated for MAC or 2 have moderate or severe lung disease due to MAC that has not been previously treated may be eligible for this study
Participants will be randomly assigned to one of two treatment groups Group 1 will receive 500 micrograms of interferon gamma-1b 3 times a week for 48 weeks by inhalation Group 2 will inhale a placebo inactive substance according to the same regimen In addition all patients will receive standard MAC treatment with three antibiotics-clarithromycin or azithromycin ethambutol and rifampin or rifabutin-taken by mouth times a week
Patients will come to the clinic for a screening visit baseline visit 1 month after beginning treatment and at 3-month intervals thereafter until the end of the study During these various visits they will undergo the following tests and procedures
Medical history and physical examination including height and weight measurements heart rate breathing rate blood pressure and temperature
Possibly computed tomography CT and X-ray of the lungs
Sputum sample
Pulmonary function studies
Blood and urine tests
Patients eyes will be examined monthly to check for side effects of ethambutol and hearing and balance will be tested to check for side effects of clarithromycin or azithromycin
At the baseline visit the patient or caretaker will be trained to use a nebulizer a special breathing device to take the study medication
Detailed Description:
Nontuberculous mycobacterial infections due to Mycobacterium avium complex MAC are a growing problem among older Americans especially women These organisms are relatively resistant to antituberculous medications and frequently persist or recur In patients with disseminated infections interferon gamma has been shown to be a critical cytokine in the resistance to and therapy of these infections Previous experience with injected interferon gamma has been relatively disappointing with clinical response rates in conventional therapy-refractory patients of about 20 Aerosol administration of interferon gamma has been shown to rapidly convert sputum smears to negative in multidrug resistant tuberculosis and in one case of MAC infection However in these short-term experiments cultures have remained positive and patients have had clinical relapse In addition aerosol administration of interferon gamma has significantly less systemic activation and side effects than does systemic administration Therefore we propose to administer interferon gamma by aerosol into the lungs of patients with MAC infection that has persisted despite adequate conventional therapy This aerosol will be delivered 3 times weekly by the patient This trial is randomized and double blinded The period of therapy is 48 weeks and the follow up is another 48 weeks All patients must be on conventional therapy at the same time and have organisms that are macrolide sensitive Screening and treatment will be conducted at the NIH Clinical Center as well as multiple collaborative sites This study should clarify the therapeutic role for aerosolized interferon gamma in the treatment of nontuberculous mycobacterial infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-I-0205 | None | None | None |