Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000974
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis Carinii Pneumonia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of the Safety Tolerance and Study of the Pharmacokinetics of Aerosolized Pentamidine and Parenteral Pentamidine in Children With HIV Infection and Suspected Pneumocystis Carinii Pneumonia
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 evaluate the delivery of a single dose of aerosolized pentamidine to children to evaluate the tolerance of pentamidine administration by mask to compare intravenous pentamidine first dose pharmacokinetics blood levels in children with information previously collected on adults and to compare plasma pentamidine levels in children after an aerosolized treatment with levels previously collected on adults
Pneumocystis carinii pneumonia PCP is the most common serious infection in children with AIDS and is associated with a high death rate Current approved treatment includes intravenous trimethoprim - sulfamethoxazole TMP SMX and intravenous pentamidine which are both effective in treatment of the first episode of PCP pneumonia However both therapies have a 50 percent or greater incidence of adverse reactions Because of serious toxicities drug treatment has had to be discontinued Animal studies show that aerosolized pentamidine pentamidine given through inhalation is as effective as intravenous pentamidine It is hoped that the aerosolized route will be less toxic than intravenous pentamidine The study is the first step in evaluating the delivery of aerosolized pentamidine to children
Pneumocystis carinii pneumonia PCP is the most common serious infection in children with AIDS and is associated with a high death rate Current approved treatment includes intravenous trimethoprim - sulfamethoxazole TMP SMX and intravenous pentamidine which are both effective in treatment of the first episode of PCP pneumonia However both therapies have a 50 percent or greater incidence of adverse reactions Because of serious toxicities drug treatment has had to be discontinued Animal studies show that aerosolized pentamidine pentamidine given through inhalation is as effective as intravenous pentamidine It is hoped that the aerosolized route will be less toxic than intravenous pentamidine The study is the first step in evaluating the delivery of aerosolized pentamidine to children
Detailed Description:
Pneumocystis carinii pneumonia PCP is the most common serious infection in children with AIDS and is associated with a high death rate Current approved treatment includes intravenous trimethoprim - sulfamethoxazole TMP SMX and intravenous pentamidine which are both effective in treatment of the first episode of PCP pneumonia However both therapies have a 50 percent or greater incidence of adverse reactions Because of serious toxicities drug treatment has had to be discontinued Animal studies show that aerosolized pentamidine pentamidine given through inhalation is as effective as intravenous pentamidine It is hoped that the aerosolized route will be less toxic than intravenous pentamidine The study is the first step in evaluating the delivery of aerosolized pentamidine to children
Sixteen patients are assigned into one of the following groups Group 1 four patients receives intravenous pentamidine as a one-time dose infused over 2 hours Group 2a six patients receives aerosolized pentamidine via face mask Group 2b six patients receives aerosolized pentamidine 2 times Group 2b will be studied only if initial dose is well tolerated Small amounts 1 - 2 cubic centimeters of blood is taken from all groups at 40 minutes and 2 3 7 14 and 24 hours from the beginning of pentamidine treatment and at the same time as the lung biopsy or bronchial alveolar lavage Patients are given routine TMP SMX or whatever medications are considered appropriate by the patients primary physician for medical management dosing 1 - 2 hours after pentamidine is given Bronchial alveolar lavage fluid or lung tissue from biopsy will be obtained between 2 - 48 hours after initiation of pentamidine treatment optionally 10 - 24 hours post dose
Sixteen patients are assigned into one of the following groups Group 1 four patients receives intravenous pentamidine as a one-time dose infused over 2 hours Group 2a six patients receives aerosolized pentamidine via face mask Group 2b six patients receives aerosolized pentamidine 2 times Group 2b will be studied only if initial dose is well tolerated Small amounts 1 - 2 cubic centimeters of blood is taken from all groups at 40 minutes and 2 3 7 14 and 24 hours from the beginning of pentamidine treatment and at the same time as the lung biopsy or bronchial alveolar lavage Patients are given routine TMP SMX or whatever medications are considered appropriate by the patients primary physician for medical management dosing 1 - 2 hours after pentamidine is given Bronchial alveolar lavage fluid or lung tissue from biopsy will be obtained between 2 - 48 hours after initiation of pentamidine treatment optionally 10 - 24 hours post dose
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 |
|---|---|---|---|
| 11090 | REGISTRY | DAIDS ES Registry Number | None |