Pentoxifylline in Children With Malaria

Status Terminated

Clinical Trial 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.

Clinical Trial 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 than/equal to 9 months and less than/equal 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 mg/kg/24 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, and/or parasitological effects (pharmacodynamics). ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00133393
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Terminated
Phase	Phase 2
Start date	January 2002
Completion date	July 2005

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.