NCT03814616

Brief Summary

This study will assess the efficacy of Pyramax administered for three-day, two-day or one day, in clearing a P. falciparum infection in asymptomatic carriers. .

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
unknown

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

September 13, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

September 13, 2018

Last Update Submit

September 27, 2019

Conditions

Malaria,Falciparum

Keywords

Asymptomatic malaria

Outcome Measures

Primary Outcomes (1)

  • PCR-adjusted APR at Day 28 (based on slide assessment by microscopy)

    To assess the efficacy of each dosing regimen PCR-adjusted Adequate parasitological response (APR) at Day 28

    Day 28

Secondary Outcomes (13)

  • PCR-adjusted APR

    63 days

  • PCR-unadjusted APR

    63 days

  • Rate of recurrent infections, recrudescence and new infections

    63 days

  • Proportion of parasite free participants

    4 days

  • Gametocyte incidence

    14 days

  • +8 more secondary outcomes

Other Outcomes (5)

  • Parasite free by qPCR quantification

    63 days

  • PCR-adjusted APR by qPCR

    63 days

  • Percentage change in gametocytaemia.

    63 days

  • +2 more other outcomes

Study Arms (3)

Arm Pyramax 3 days

EXPERIMENTAL

Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for three days (Arm A)

Drug: Pyronaridine tetraphosphate 180mg:artesunate 60mg

Arm Pyramax 2 days

EXPERIMENTAL

Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for two days (Arm B)

Drug: Pyronaridine tetraphosphate 180mg:artesunate 60mg

Arm Pyramax 1 day

EXPERIMENTAL

Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for one day (Arm C)

Drug: Pyronaridine tetraphosphate 180mg:artesunate 60mg

Interventions

Pyronaridine tetraphosphate 180mg:artesunate 60mgDRUG

ACT

Also known as: Pyramax
Arm Pyramax 1 dayArm Pyramax 2 daysArm Pyramax 3 days

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Evidence of asymptomatic infection with Plasmodium falciparum monoinfection on thin and thick blood smears with parasite density between 20/µL and 50,000/µL
  • Absence of any clinical symptoms of malaria at the time of enrolment and within 72 hours before enrolment
  • Age \>5 years old and \>20 kg body weight
  • Ability to swallow oral medication
  • Evidence of a personally signed and dated Informed Consent document indicating that the participant (or a legally acceptable representative if a participant is \<18 years of age) has been informed of all pertinent aspects of the study and that all questions by the participant have been sufficiently answered. Assent will be obtained from participants \<18 years of age as required by national regulations.
  • Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

  • Haemoglobin \<7 g/dL (measured at screening)
  • History of having received any antimalarial treatment (alone or in combination) during the following periods before screening:
  • Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks prior to screening
  • Amodiaquine, chloroquine within 4 weeks prior to screening
  • Any artemisinin derivative (artesunate, artemether or dihydroartemisinin), quinine, lumefantrine or any other anti-malarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and azithromycin) within 14 days prior to screening
  • Any herbal products or traditional medicines during the 7 days prior to screening (if spontaneously reported by the patient)
  • Known allergy to the study drugs (pyronaridine and/or any artemisinin derivatives)
  • Positive urinary pregnancy test for women of reproductive age
  • Lactating women
  • Evidence of severe malnutrition
  • Participation in other studies within 30 days before the current study begins and/or during study participation
  • Inability to comprehend and/or unwillingness to follow the study protocol
  • Previously randomized in this study
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Examples would include but not limited to:
  • Immunological disorders (including known seropositive HIV antibody),
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine,

Fajara, City of Banjul, The Gambia

Location

Tropical Diseases Research Centre

Ndola, Zambia

Location

Related Publications (1)

  • Dabira ED, Hachizovu S, Conteh B, Mendy A, Nyang H, Lawal B, Ndiath MO, Mulenga JM, Mwanza S, Borghini-Fuhrer I, Arbe-Barnes S, Miller R, Shin J, Duparc S, D'Alessandro U, Manyando C, Achan J. Efficacy, Safety and Tolerability of Pyronaridine-artesunate in Asymptomatic Malaria-infected Individuals: a Randomized Controlled Trial. Clin Infect Dis. 2022 Jan 29;74(2):180-188. doi: 10.1093/cid/ciab425.

    PMID: 33983371DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

pyronaridineArtesunatepyronaridine tetraphosphate, artesunate drug combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Jang Sik Shin

    Shin Poong

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

January 24, 2019

Study Start

October 3, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

ZA(1)TH(1)