NCT02389439

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 20, 2018

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

January 29, 2015

Last Update Submit

September 18, 2018

Conditions

Malaria, Falciparum

Outcome Measures

Primary Outcomes (1)

  • result of PCR

    42 day

Secondary Outcomes (10)

  • hepatic biological values

    at day 0, 3,7 and day 28

  • eosinophil count

    at day 0, 3, 7 and day 28

  • K13 and pfmdr1 of P falciparum resistance

    at day 0, 3, 7 and day 28

  • numbers of patients with a positive malaria slide 72 hours after treatment initiation

    72 hours

  • fever clearance time

    24 hours

  • +5 more secondary outcomes

Study Arms (1)

Pyronaridine-artesunate

EXPERIMENTAL

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

Interventions

Pyronaridine-artesunateDRUG
Also known as: Pyramax
Pyronaridine-artesunate

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tasanh Health Centre, Battambang

Battambang, Cambodia

Location

Referral hospital (Pailin)

Pailin, Cambodia

Location

Promoy Health Centre (Pursat)

Pursat, Cambodia

Location

Related Publications (1)

  • Leang R, Canavati SE, Khim N, Vestergaard LS, Borghini Fuhrer I, Kim S, Denis MB, Heng P, Tol B, Huy R, Duparc S, Dondorp AM, Menard D, Ringwald P. Efficacy and Safety of Pyronaridine-Artesunate for Treatment of Uncomplicated Plasmodium falciparum Malaria in Western Cambodia. Antimicrob Agents Chemother. 2016 Jun 20;60(7):3884-90. doi: 10.1128/AAC.00039-16. Print 2016 Jul.

    PMID: 26926629DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

pyronaridine tetraphosphate, artesunate drug combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

September 20, 2018

Record last verified: 2015-04

Locations

CA(3)