Overview
Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria
Status:
Completed
Completed
Trial end date:
2017-02-02
2017-02-02
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine the efficacy and safety of imatinib in combination with dihydroartemisinin plus piperaquine in the treatment uncomplicated P. falciparum malaria in adult male patients.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
HuLowCollaborators:
Hue University
Purdue University
Università degli Studi di Sassari
University of Turin, ItalyTreatments:
Artemisinins
Artenimol
Dihydroartemisinin
Imatinib Mesylate
Piperaquine
Criteria
Inclusion Criteria:- Gender: only adults are selected for the trial; note that female subjects cannot be
women of child-bearing age.
- Age: 18-50 years.
- Target disease: Uncomplicated Plasmodium falciparum malaria
Exclusion Criteria:
- symptoms and signs of complicated malaria
- including continuous high fever of over 390C, psychiatric disorders, confusion, other
neurological symptoms, symptoms and signs of functional impairment of the organs such
as lungs, kidneys or cardiovascular system;
- symptoms and signs of liver damage or kidney damage
- symptoms and signs of another complicating infection such as pneumonia, dengue fever,
and other bacterial infection.
- P. falciparum > 25.000 / mm3
- WBC <4000 and >10.000 /mm3
- RBC < 3.5x106/mm3
- Platelets < 40.000 /mm3
- Hemoglobin < 10 g/dL
- ALT more than 200% of the upper limit (56 units/L)
- AST more than 200% of the upper limit (40 units/L)
- Blood creatine more than 75% of the upper limit (men: 1.2 mg/dL, women 1 mgdL)
- Serum total protein < 6 g/L
- Glycemia < 50 mg/dL> 200 mg/dL
- Standard urine test Serious alterations
- Concomitant treatments
Antimalarial Drugs Anticoagulant therapy