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Evaluation of Fosmidomycin and Piperaquine in the Treatment of Acute Falciparum Malaria (FOSPIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02198807
Recruitment Status : Unknown
Verified June 2015 by Jomaa Pharma GmbH.
Recruitment status was:  Active, not recruiting
First Posted : July 24, 2014
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
Centre de Recherche Médicale de Lambaréné
Information provided by (Responsible Party):
Jomaa Pharma GmbH

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 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.


Condition or disease Intervention/treatment Phase
Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria Drug: Fosmidomycin-Piperaquine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Fosmidomycin-Piperaquine
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
Drug: Fosmidomycin-Piperaquine



Primary Outcome Measures :
  1. Per protocol, PCR-corrected cure rate on Day 28 [ Time Frame: 28 days ]

    Six-hourly asexual counts until negative on three successive occasions.

    Weekly smears on days 7, 14, 21 and 28



Secondary Outcome Measures :
  1. Per protocol, PCR-corrected cure rates on Day 7 and Day 63 [ Time Frame: 63 days ]
    Weekly smears on days 35 +/- 3 days, 42 +/- 3 days and 63 +/- 3 days

  2. Derived parasite reduction ratio at 48 hours [ Time Frame: 2 days ]
    Six-hourly asexual counts until negative on three successive occasions

  3. Parasite clearance time [ Time Frame: 96 hours ]
    Six-hourly asexual counts until negative on three successive occasions

  4. Fever clearance time [ Time Frame: 96 hours ]
    Six hourly temperature recordings until normal on three successisve occasions

  5. Proportion of subjects with gametocytes on Day 7 [ Time Frame: 7 days ]
    Smear on Day 7

  6. Adverse event recording [ Time Frame: 28 days ]

    Recording of vital signs and ECG monitoring

    Recording of incidence, severity, drug-relatedness and seriousness of AEs and laboratory abnormalites




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Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jomaa Pharma GmbH
ClinicalTrials.gov Identifier: NCT02198807    
Other Study ID Numbers: JP017
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Piperaquine
Fosmidomycin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents