Pentoxifylline in Children With Malaria (NCT00133393) | Clinical Trial Compass
TerminatedPhase 2
Pentoxifylline in Children With Malaria
Kenya50 participantsStarted 2002-01
Plain-language 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.
Who can participate
Age range9 Months – 96 Months
SexALL
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Inclusion Criteria:
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 Criteria:
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%.
Trial details
NCT IDNCT00133393
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)