Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000707
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Aerosols in the Treatment of Asymptomatic Pneumocystis Pneumonia A Pilot Study Assessing the Effectiveness of Aerosolized Pentamidine as Treatment of Subclinical Pneumocystis Infection in Patients With No Clinical Symptoms
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Aerosols in the Treatment of Asymptomatic Pneumocystis Pneumonia A Pilot Study Assessing the Effectiveness of Aerosolized Pentamidine as Treatment of Subclinical Pneumocystis Infection in Patients With No Clinical Symptoms
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To confirm the ability of pulmonary lung function testing PFT to detect Pneumocystis carinii pneumonia PCP before the development of clinical symptoms and to determine if pentamidine PEN a drug used in treating PCP can be given effectively as an aerosol inhaled mist Other goals include the measurement of the actual amount of PEN that reaches the lung and to determine if close clinical observation is safer and as effective as drug therapy for the prevention of subsequent episodes of PCP
Many AIDS patients develop PCP but the effectiveness of early diagnosis and treatment of PCP is not known The effectiveness of PEN may be improved if treatment is begun when the parasite burden the number of organisms in the lung is still small and before respiratory symptoms appear If PFT of HIV-infected patients is able to identify patients in the early stages of infection outpatient treatment of these patients offers a possible alternative to the expense and toxicity of continuous preventive therapy of all high-risk patients
Many AIDS patients develop PCP but the effectiveness of early diagnosis and treatment of PCP is not known The effectiveness of PEN may be improved if treatment is begun when the parasite burden the number of organisms in the lung is still small and before respiratory symptoms appear If PFT of HIV-infected patients is able to identify patients in the early stages of infection outpatient treatment of these patients offers a possible alternative to the expense and toxicity of continuous preventive therapy of all high-risk patients
Detailed Description:
Many AIDS patients develop PCP but the effectiveness of early diagnosis and treatment of PCP is not known The effectiveness of PEN may be improved if treatment is begun when the parasite burden the number of organisms in the lung is still small and before respiratory symptoms appear If PFT of HIV-infected patients is able to identify patients in the early stages of infection outpatient treatment of these patients offers a possible alternative to the expense and toxicity of continuous preventive therapy of all high-risk patients
Patients are treated with aerosolized PEN on an outpatient basis The aerosol therapy is given by a respiratory therapist 5 times a week for a total of 21 days of treatment In addition patients participate in two radioactive aerosol studies in which the patient inhales a radioactive gas while sitting with hisher back against a gamma camera The resulting picture outlines the lungs Then the gas is exhaled and the patient breathes an aerosol of PEN This mist contains a single dose of PEN mixed with a small amount of radioactivity 99mTc-pertechnetate The gamma camera determines where the particles deposit in the lungs The radioactive exposure is equivalent to a typical x-ray of the ribs Patients also undergo diagnostic bronchoscopy with lavage and PFT Blood is drawn to measure the blood level of PEN Patients are followed clinical exams and PFTs for 6 months after the end of therapy Prophylaxis for PCP is allowed during the 6-month follow-up
Patients are treated with aerosolized PEN on an outpatient basis The aerosol therapy is given by a respiratory therapist 5 times a week for a total of 21 days of treatment In addition patients participate in two radioactive aerosol studies in which the patient inhales a radioactive gas while sitting with hisher back against a gamma camera The resulting picture outlines the lungs Then the gas is exhaled and the patient breathes an aerosol of PEN This mist contains a single dose of PEN mixed with a small amount of radioactivity 99mTc-pertechnetate The gamma camera determines where the particles deposit in the lungs The radioactive exposure is equivalent to a typical x-ray of the ribs Patients also undergo diagnostic bronchoscopy with lavage and PFT Blood is drawn to measure the blood level of PEN Patients are followed clinical exams and PFTs for 6 months after the end of therapy Prophylaxis for PCP is allowed during the 6-month follow-up
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11022 | REGISTRY | DAIDS ES Registry Number | None |