Status:
TERMINATED
Pentoxifylline in Children With Malaria
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
9-96 years
Phase:
PHASE2
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 m...
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 than/equal...
Eligibility Criteria
Inclusion
- Children meeting all of the following criteria are eligible for inclusion in the study.
- Age greater than or equal to 9 months and less than or equal to 96 months. Informed consent granted by parents/guardians (Appendix I).
- Has cerebral malaria defined as all of the following:
- peripheral parasitemia with asexual forms of P. falciparum; inability to localize a painful stimulus 30 minutes after correcting hypoglycemia (blood glucose less than 2.2 mmol/l) in patients who present with hypoglycemia 30 minutes after cessation of convulsive activity in patients who are convulsing on admission; no neck stiffness; no clinical evidence of pneumonia (no rales, no decreased breath sounds, no bronchial breathing).
Exclusion
- Children with the following will not be enrolled in the study:
- Hypotension: mean blood pressure less than 60 mmHg (mean blood pressure = diastolic blood pressure (mmHg) + 1/3 (systolic blood pressure
- diastolic blood pressure)). Thrombocytopenia: platelet count less than 50 x 10(to the ninth power)/l. Spontaneous bleeding noted in mouth, throat, nares, rectum, or a venipuncture site following adequate pressure.
- Hematocrit \< 20% OR hematocrit between 20-25% with parasitemia greater than 10%.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00133393
Start Date
January 1 2002
End Date
July 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
KEMRI Centre for Geographic Medicine Research
Kilifi, Kenya