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Short Course Radical Cure of P. Vivax Malaria in Nepal

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ClinicalTrials.gov Identifier: NCT04079621
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Tribhuvan University, Nepal
Information provided by (Responsible Party):
Menzies School of Health Research

Brief Summary:
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Condition or disease Intervention/treatment Phase
Malaria Malaria, Vivax Malaria,Falciparum Drug: primaquine Phase 4

Detailed Description:

Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite.

In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P.vivax malaria following treatment of P falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P.vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections.

The recently completed multicentre IMPROV study compared the efficacy of a 7 day PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control.

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Course Radical Cure of P.Vivax in Nepal
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: (P.f)
patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days plus a low dose course of primaquine (PQ) (3.5mg/kg total dose) given 7 days during schizontocidal treatment
Drug: primaquine
Primaquine regimen over 7 days (0.5mg/kg/day for 7 days)
Other Name: Jasoprim, Malirid, Neo-Quipenyl, Pimaquin, Pmq, Primachina, Primacin, Primaquina, Primaquine, Primaquine diphosphate, Primaquine Phosphate, and Remaquin

Experimental: (P.v)
patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (3.5mg/kg total dose) given over 7 days during schizontocidal treatment.
Drug: primaquine
Primaquine regimen over 7 days (0.5mg/kg/day for 7 days)
Other Name: Jasoprim, Malirid, Neo-Quipenyl, Pimaquin, Pmq, Primachina, Primacin, Primaquina, Primaquine, Primaquine diphosphate, Primaquine Phosphate, and Remaquin

No Intervention: Standard care (P.f)
patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days (plus a single dose PQ)
No Intervention: Standard care (P.v)
patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (total dose 3.5mg/kg) over 14 days



Primary Outcome Measures :
  1. Incidence Risk of P. vivax relapse at month 6 [ Time Frame: 6 months ]
    The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax and P. falciparum infection.


Secondary Outcome Measures :
  1. The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax [ Time Frame: 6 months ]
  2. The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. falciparum [ Time Frame: 6 month ]
  3. The incidence risk of symptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection [ Time Frame: Day 28 ]
  4. The incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection [ Time Frame: Day 28 ]
  5. The incidence risk of asymptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection [ Time Frame: Day 28 ]

Other Outcome Measures:
  1. The proportion of patients vomiting their medication within 1 hour of administration [ Time Frame: 1 h ]
  2. The proportion of patients vomiting any of their PQ doses during the supervised course [ Time Frame: 7 - 14days ]
  3. The proportion of adverse events and serious adverse events [ Time Frame: 6 month ]
  4. The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion [ Time Frame: 6 month ]
  5. Risk of greater than 25% fall in haemoglobin on any day of treatment [ Time Frame: 7-14days ]
  6. The incidence risk of an acute drop in Hb of >5g/dl during PQ treatment [ Time Frame: 7-14days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • P. falciparum and/or vivax infection
  • Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
  • Age >1 years
  • G6PD normal by Rapic Diagnosic Test (RDT) as per national guidelines
  • Written informed consent
  • Able to comply with all study procedures and timelines

Exclusion Criteria:

  • General danger signs or symptoms of severe malaria
  • Anaemia, defined as Hb <8g/dl
  • Pregnant women as determined by Urine β-HCG pregnancy test
  • Breast feeding women
  • Known hypersensitivity to any of the drugs given
  • Regular use of drugs with haemolytic potential
  • Blood transfusion within the last 4 months

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): NCT04079621


Contacts
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Contact: Kamala Ley-Thriemer, MD,PhD 0889468644 kamala.ley-thriemer@menzies.edu.au

Sponsors and Collaborators
Menzies School of Health Research
Tribhuvan University, Nepal
Investigators
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Principal Investigator: Kamala Ley-Thriemer, MD, PhD Menzies School of Health Research
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Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT04079621    
Other Study ID Numbers: NEPAL2019
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Primaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents