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Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

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ClinicalTrials.gov Identifier: NCT00331136
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : May 20, 2008
Sponsor:
Collaborators:
Shin Poong Pharmaceuticals
Institute of Tropical Medicine, University of Tuebingen
Information provided by:
Medicines for Malaria Venture

Brief Summary:
The purpose of this study is to evaluate three dose levels of a combination of pyronaridine and artesunate for the treatment of uncomplicated falciparum malaria in children.

Condition or disease Intervention/treatment Phase
Uncomplicated Plasmodium Falciparum Malaria Drug: Pyronaridine-Artesunate Phase 2

Detailed Description:
Plasmodium falciparum malaria kills over one million people and results in up to 500 million cases annually affecting mainly young children and pregnant women. The economic consequences of malaria are enormous in endemic regions with an estimated USD 12 billion per year lost GDP and a loss of 45 million years of productive life due to deaths and disability. Malaria is curable and preventable, with principal control strategies including rapid diagnosis, effective treatment and personal protection with bed nets. Currently a number of antimalarials are available, however two of the most widely used drugs, chloroquine and sulfadoxine-pyrimethamine are not effective in many parts of the world due to drug resistance. Artemisinin-based combination therapies (ACT) are effective and today are considered by experts the best antimalarials in terms of efficacy and a lower propensity to resistance. Cost and access to appropriate quality raw materials remain major issues with the currently available artemisinins. In order to prevent the occurrence of drug resistance to artemisinins and to address the issue of its relatively short half-life, artemisins are recommended to be given in combination with another antimalarial agent. In this development programme, artemisinin, as artesunate, is being partnered with an established antimalarial agent pyronaridine. The objective of the development programme for the pyronaridine artesunate combination is to develop a three day oral therapy for use in children and adults to treat acute, uncomplicated malaria.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase II, Dose-Escalation Clinical Study to Assess the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Fixed Dose Combination of Pyronaridine and Artesunate (3:1) In Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Study Start Date : June 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 1
Pyronaridine artesunate 6:2 mg/kg
Drug: Pyronaridine-Artesunate
once a day for 3 days
Other Name: Pyramax

Experimental: 2
Pyronaridine artesunate 9:3 mg/kg
Drug: Pyronaridine-Artesunate
once a day for 3 days
Other Name: Pyramax

Experimental: 3
Pyronaridine artesunate 12:4 mg/kg
Drug: Pyronaridine-Artesunate
once a day for 3 days
Other Name: Pyramax




Primary Outcome Measures :
  1. To determine the PK of once daily dosing for 3 days of 3 dose levels of pyronaridine artesunate in children weighing between 10 and 40 kg [ Time Frame: Day 42 ]
  2. To determine the safety and tolerability of 3 dose levels of the fixed tablet formulation of pyronaridine:artesunate (3:1). [ Time Frame: 42 Days ]

Secondary Outcome Measures :
  1. Proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28 [ Time Frame: Day 28 ]
  2. Parasite Clearance Time [ Time Frame: Day 3 ]
  3. Fever Clearance Time [ Time Frame: Day 3 ]
  4. Parasite reduction rate index [ Time Frame: Day 28 ]
  5. Proportion of treatment success or failures [ Time Frame: Day 28 ]
  6. Proportion of patients with PCR-corrected ACPR on Day 14 [ Time Frame: Day 14 ]
  7. Proportion of patients who have cleared parasites at Day 1, 2 and 3 [ Time Frame: Days 1, 2, 3 ]
  8. Proportion of patients who have fever cleared at Day 1, 2 and 3 [ Time Frame: Days 1, 2, 3 ]
  9. Number of gametocytes per μl at Days 0, 3, 7, 14, 21, 28 and 42 [ Time Frame: Day 42 ]
  10. Crude ACPR on Day 14, 28 and 42 [ Time Frame: Days 14, 28, 42 ]
  11. PCR-corrected ACPR on Day 42 [ Time Frame: Day 42 ]


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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients presenting with symptoms of acute uncomplicated falciparum malaria with the following inclusion criteria :

  • Male or female children, being between 2 and 14 years of age inclusive
  • Weight between 10 and 40 kg inclusive
  • Written informed consent, in accordance to local practice, provided by parent/guardian. If the parent/guardian is unable to write, witnessed consent is permitted according to local ethical considerations. Where possible, parent assent will be sought.
  • Absence of severe malnutrition (defined as Mid Upper arm Circumference <110mm)
  • Presence of acute symptomatic uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only (i.e. no mixed infection) plus measured temperature of ≥37.5°C (depending on method of measurement as below) or history of fever within the past 24 hours :
  • the acceptable range is between 1,000 and 200,000 asexual parasite count/μl of blood and
  • axillary/tympanic temperature of ≥37.5°C or oral/rectal temperature of ≥38.0°C

Exclusion Criteria:

  • Patients with signs and symptoms of severe/complicated malaria requiring parenteral antimalarial treatment according to the World Health Organization Criteria 2000
  • Mixed Plasmodium infection
  • Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more watery stools per day
  • Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 mseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
  • Presence of febrile conditions caused by diseases other than malaria
  • Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
  • Use of any other antimalarial treatment within 2 weeks prior to start of the study as confirmed by Lignin test and Saker Solomon urine test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331136


Locations
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Gabon
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné, Gabon
Sponsors and Collaborators
Medicines for Malaria Venture
Shin Poong Pharmaceuticals
Institute of Tropical Medicine, University of Tuebingen
Investigators
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Principal Investigator: Michael Ramharter, MD Albert Schweitzer Hospital, Lambaréné, Gabon

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Isabelle Borghini Fuhrer, Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT00331136     History of Changes
Obsolete Identifiers: NCT00329875
Other Study ID Numbers: SP-C-003-05
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
Keywords provided by Medicines for Malaria Venture:
malaria
pyronaridine
artesunate
falciparum
ACT
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Pyronaridine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics