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Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria

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ClinicalTrials.gov Identifier: NCT02389439
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
NCHADS - Ministry of Health of Cambodia
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.

All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.

Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).


Condition or disease Intervention/treatment Phase
Malaria, Falciparum Drug: Pyronaridine-artesunate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Pyronaridine-artesunate

Pyronaridine-artesunate (Pyramax®, Shin Poong Pharmaceuticals). One tablet contains 60mg artesunate+ 180mg pyronaridine. Dosing will be according to body weight.

It will be taken orally with water, once daily for 3 days. Each dose will be administered under the supervision. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only.

20 - < 24 kg = 1 tab 24 - < 45 kg = 2 tabs 45 - < 65 kg = 3 tabs 65 and above = 4 tabs

Drug: Pyronaridine-artesunate
Other Name: Pyramax




Primary Outcome Measures :
  1. result of PCR [ Time Frame: 42 day ]

Secondary Outcome Measures :
  1. hepatic biological values [ Time Frame: at day 0, 3,7 and day 28 ]
    the hepatic biological values will be measured which are AST,ALT,albumin and total bilirubin

  2. eosinophil count [ Time Frame: at day 0, 3, 7 and day 28 ]
  3. K13 and pfmdr1 of P falciparum resistance [ Time Frame: at day 0, 3, 7 and day 28 ]
  4. numbers of patients with a positive malaria slide 72 hours after treatment initiation [ Time Frame: 72 hours ]
  5. fever clearance time [ Time Frame: 24 hours ]
    the time taken for tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours

  6. Number of patient with reinfection and recrudescences [ Time Frame: over 42 days ]
  7. PCR uncorrected ACPR [ Time Frame: at 28 days or 42 days ]
    PCR uncorrected ACPR at 28 days or 42 days for P. falciparum, P. falciparum and mixed infections in Pailin

  8. PCR corrected ACPR [ Time Frame: at 28 days and 42 days ]
    PCR corrected ACPR at 28 days or for P. falciparum, P. vivax and mixed infections and at 42 days for P. falciparum and mixed infections

  9. Gametocyte carriage rates [ Time Frame: at day 0, 3, 7 day 28 ]
  10. gametocyte clearance times [ Time Frame: at day 0, 3, 7 and day28 ]


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults and children ≥ 20 kg
  • Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever >37.5°c.
  • Microscopic confirmation of asexual stages of P. falciparum (P. falciparum and mixed infection in Pailin only)
  • Capability of taking an oral medication
  • Written informed consent given to participate in the trial
  • Willingness and ability to adhere to follow-up visit schedule

Exclusion Criteria:

  • Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age, that is 18 to 45 y/o)
  • Female aged 12-18y
  • Parasitemia > 150 000/µL).
  • Signs or symptoms indicative of severe malaria:

    • Impaired consciousness (Blantyre Coma Score <5)
    • Severe anaemia (Hct<15%)
    • Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites
    • Respiratory distress
    • Severe jaundice
  • Known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or to pyronaridine
  • History of splenectomy
  • Known history or evidence of clinically significant disorders, such as:

    • Known active Hepatitis A, e.g. by detection of anti HAV-IgM.
    • Known hepatitis B surface antigen (HBsAg) carrier.
    • Known hepatitis C antibody (HCV Ab).
    • Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range.

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): NCT02389439


Locations
Cambodia
Tasanh Health Centre, Battambang
Battambang, Cambodia
Referral hospital (Pailin)
Pailin, Cambodia
Promoy Health Centre (Pursat)
Pursat), Cambodia
Sponsors and Collaborators
University of Oxford
NCHADS - Ministry of Health of Cambodia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02389439     History of Changes
Other Study ID Numbers: Cambodia1
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: April 2015

Additional relevant MeSH terms:
Antimalarials
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Pyronaridine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents