Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000722
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Aerosols in the Treatment of Pneumocystis Pneumonia A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy
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 Pneumocystis Pneumonia A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy
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 compare the use of pentamidine aerosol inhaled mist with the standard intravenous method of administration in patients with AIDS related Pneumocystis carinii pneumonia PCP to measure the amount of pentamidine aerosol that actually reaches the lung and to see if close clinical observation is safer and as effective as drug therapy in the prevention of PCP recurrences To compare the efficiency of 2 nebulizers - the Respirgard II nebulizer and the Cadema Aerotech II nebulizer Aerosolized pentamidine was as effective as intravenous pentamidine in treating PCP in animals More of the pentamidine reached the lungs and less was found in the liver and kidney after pentamidine was given by aerosol than after an intravenous injection This suggests that the toxicity of pentamidine may be less if given by aerosol than if given by the intravenous route
Detailed Description:
Aerosolized pentamidine was as effective as intravenous pentamidine in treating PCP in animals More of the pentamidine reached the lungs and less was found in the liver and kidney after pentamidine was given by aerosol than after an intravenous injection This suggests that the toxicity of pentamidine may be less if given by aerosol than if given by the intravenous route
Patients will inhale one dose of radiolabeled aerosol containing pentamidine and an image of the lung will be taken immediately and then 24 hours later to determine the amount of pentamidine reaching the various areas of the lung Patients will then undergo a bronchoalveolar lavage BAL in order to recover the PCP organism from the lung and to corroborate the diagnosis of PCP If PCP organisms are detected patients will be randomly assigned to aerosolized or intravenous pentamidine and treated for 21 days Patients taking pentamidine by aerosol will repeat the radiolabeled aerosol study on day 9 The BAL will be repeated at the end of therapy for all patients If patients do not improve within 9 days they will be switched to another therapy After completion of therapy patients will be given the option of prophylactic therapy ie doses of medication to prevent reinfection for PCP All patients will be carefully assessed every 4 weeks for 6 months whether they begin prophylactic therapy or not Zidovudine AZT may not be taken during the 21-day trial because of the increased risk of side effects but it can be resumed when PCP therapy is completed
Patients will inhale one dose of radiolabeled aerosol containing pentamidine and an image of the lung will be taken immediately and then 24 hours later to determine the amount of pentamidine reaching the various areas of the lung Patients will then undergo a bronchoalveolar lavage BAL in order to recover the PCP organism from the lung and to corroborate the diagnosis of PCP If PCP organisms are detected patients will be randomly assigned to aerosolized or intravenous pentamidine and treated for 21 days Patients taking pentamidine by aerosol will repeat the radiolabeled aerosol study on day 9 The BAL will be repeated at the end of therapy for all patients If patients do not improve within 9 days they will be switched to another therapy After completion of therapy patients will be given the option of prophylactic therapy ie doses of medication to prevent reinfection for PCP All patients will be carefully assessed every 4 weeks for 6 months whether they begin prophylactic therapy or not Zidovudine AZT may not be taken during the 21-day trial because of the increased risk of side effects but it can be resumed when PCP therapy is completed
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 |
|---|---|---|---|
| 11016 | REGISTRY | DAIDS ES Registry Number | None |