Trial | NCT02198807  Report issue

Title

Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria
A Phase IIa Proof of Concept Study to Explore the Efficacy, Tolerability and Safety of Fosmidomycin Sodium When Administered With Piperaquine Tetraphosphate to Adults and Older Children With Acute Uncomplicated Plasmodium Falciparum Malaria

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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 three days.

Together, fosmidomycin and piperaquine fulfil the WHO criteria for combination therapy by meeting the three key parameters of having different modes of action and different biochemical targets while exhibiting independent blood schizonticidal activity. Like the artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active against existing drug-resistant parasites. Piperaquine has a long half life protecting fosmidomycin as a much shorter lived molecule against selection of resistant parasites and will provide post-treatment prophylaxis.
Study Started
Mar 31
2014
Primary Completion
Jul 31
2014
Study Completion
Dec 31
2015
Anticipated
Last Update
Jun 15
2015
Estimate

Drug Fosmidomycin-Piperaquine

Fosmidomycin-Piperaquine Experimental

Fosmidomycin sodium capsules 450 mg, dosage: 30mg/kg twice daily for 3 days Piperaquine phosphate tablets 320 mg, dosage: 16 mg/kg once a day for 3 days

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted