Status:
UNKNOWN
Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria
Lead Sponsor:
Jomaa Pharma GmbH
Collaborating Sponsors:
Centre de Recherche Médicale de Lambaréné
Conditions:
Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
Eligibility:
All Genders
1-60 years
Phase:
PHASE2
Brief Summary
The objective of this study is to explore the role of fosmidomycin and piperaquine as non-artemisinin-based combination therapy for acute uncomplicated Plasmodium falciparum when administered over thr...
Eligibility Criteria
Inclusion
- Male and female subjects aged 1 to 60 years inclusive
- Body weight between 5kg and 90kg inclusive
- Acute manifestations of a mono-infection with Plasmodium falciparum as determined by either a rapid diagnostic test for adults or microscopically confirmed by an asexual parasitaemia of 1,000 to 150,000/uL and fever with an axillary temperature of \> 37.5 degress C or oral/rectal/tympanic temperature of \> 38.0 degrees C or history of fever during the previous 72 hours
- Compliance with contraceptive measures throughout the study period of 63 days in females of child bearing potential
Exclusion
- To be eligible for inclusion in the study, subjects must NOT meet any of the following criteria:
- Signs of severe/complicated malaria according to WHO criteria
- Pregnancy as excluded by negative serum human chorionic gonadotrophin (hCG) test
- Lactation
- Mixed Plasmodium infection
- Severe vomiting on three or more occasions in the previous 24 hours
- Severe diarrhoea on four or more occasions in the previous 24 hours
- Concomitant disease masking assessment of response including
- abnormal liver function tests with bilirubin \> 40 µmol/L, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) levels \> x 2 upper limit of normal
- impaired renal function with creatinine level \> x 2 upper limit of normal
- haemoglobin level \< 7.5g/dl
- white cell count \> 12000/µL
- History of cardiovascular disease including arrhythmia with QTc interval ≥ 450msec, respiratory disease including active tuberculosis, hepatic disease including jaundice, renal failure, malignancy, neurological disorders including convulsions and psychiatric disturbances
- History of immunological disease including Hepatitis A, B and C and HIV-AIDS
- Severe malnutrition
- History of hypersensitivity or adverse reactions to fosmidomycin, piperaquine, artesunate and mefloquine
- Treatment with antimalarial and antibacterial agents within the previous 28 days
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02198807
Start Date
March 1 2014
End Date
December 1 2015
Last Update
June 15 2015
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