Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133393
Status:
TERMINATED
Last Update Posted:
2010-08-27
First Post:
2005-08-19
Brief Title:
Pentoxifylline in Children With Malaria
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Dose Finding Study of Pentoxifylline in Children With Cerebral Malaria
Status:
TERMINATED
Status Verified Date:
2005-10
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:
The primary objectives of this study is to identify a safe tolerable dose of pentoxifylline in children with cerebral malaria and to establish an acceptable pentoxifylline dosage regimen for use in multi center Phase II and Phase III studies
Detailed Description:
This is an open prospective dose-escalating study designed to elucidate the pharmacokinetics pharmacodynamics safety and tolerability of pentoxifylline in children of the ages greater thanequal to 9 months and less thanequal to 96 months with cerebral malaria The study is designed to evaluate pentoxifylline as adjunct therapy in severe pediatric malaria by evaluating its toxicity and associated adverse events and by establishing both an acceptable dose and the associated pharmacokinetic profile The pharmacodynamic effects of four different dose levels 10 20 30 and 40 mgkg24 hours will be accessed on the following biological immunological and parasitological parameters cerebral blood flow velocity tumor necrosis factor concentration rosetting coma resolution time parasite clearance time and fever clearance time Due to the variability observed in the biological immunological and parasitological parameters under scrutiny a control group of ten patients will be intercalated in the study 4 patients prior to enrollment of the first pentoxifylline recipient 2 patients in-between each of the 3 dose escalations As there is no information about the relationship of treatment duration to biological immunological and parasitological effects treatment will continue for 72 hours by which time peripheral parasitemia will have cleared in the majority of patients The selection of the pentoxifylline dosage regimen for the larger multi center Phase II and Phase III studies will be made on the basis of the maximum tolerated dose based on clinical and laboratory observations which minimizes the dose-related side-effects and adverse events based on pharmacokinetics while permitting maximum biological immunological andor parasitological effects pharmacodynamics
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