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Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity

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ClinicalTrials.gov Identifier: NCT02143934
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : May 21, 2014
Sponsor:
Collaborators:
Walter and Eliza Hall Institute of Medical Research
Swiss Tropical & Public Health Institute
Barcelona Centre for International Health Research
Information provided by (Responsible Party):
Papua New Guinea Institute of Medical Research

Brief Summary:

This study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in children aged 5-10 years in a treatment to re-infection study design. In order the clear liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days, 0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.

In addition to this epidemiological data, the study will assess the natural acquisition of cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG children aged 5-10 years.

These data will not only be essential for development of future vaccines against P. vivax and P falciparum but provide invaluable insight into the contribution of long-lasting liver-stages to the force of infection with P. vivax that will contribute towards designing more rational approaches to the treatment of P. vivax both in the context of case management and future attempts at elimination.


Condition or disease Intervention/treatment Phase
Plasmodium Vivax Infection Plasmodium Vivax Clinical Episode Plasmodium Falciparum Infection Plasmodium Falciparum Clinical Episode Drug: Primaquine Drug: Placebo Drug: Chloroquine Drug: Artemether Lumefantrine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province
Study Start Date : August 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Primaquine
Primaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Drug: Primaquine
Drug: Chloroquine
Drug: Artemether Lumefantrine
Other Name: Coartem

Placebo Comparator: Placebo
Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Drug: Placebo
Sugar pills, appearance identical to Primaquine tablets

Drug: Chloroquine
Drug: Artemether Lumefantrine
Other Name: Coartem




Primary Outcome Measures :
  1. Time to first or only Plasmodium vivax infection by light microscopy and PCR [ Time Frame: 8 months post-baseline ]
  2. Time to first or only clinical P. vivax episode [ Time Frame: 8 months post-baseline ]

Secondary Outcome Measures :
  1. Time to first or only P. falciparum infection by light microscopy and PCR [ Time Frame: 8 months post-baseline ]
  2. Time to first or only P. ovale infection by light microscopy and PCR [ Time Frame: 8 months post-baseline ]
  3. Time to first or only P. malariae infection by light microscopy and PCR [ Time Frame: 8 months post-baseline ]


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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 5-10 years (±3 months)
  • permanent residents of the area
  • absence of history of hypersensitivity reactions to the drugs

Exclusion Criteria:

  • chronic illness
  • severe malnutrition (weight-for-age nutritional Z score [WAZ] <60th percentile)
  • severe anemia (Hb <5 g/dL),
  • G-6-PD deficiency (<60% G-6-PD activity)
  • permanent disability, which prevents or impedes study participation. Any 1 or more of the criteria is sufficient to exclude study participation.

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): NCT02143934


Locations
Papua New Guinea
PNG Institute of Medical Research
Maprik, East Sepik Province, Papua New Guinea
Sponsors and Collaborators
Papua New Guinea Institute of Medical Research
Walter and Eliza Hall Institute of Medical Research
Swiss Tropical & Public Health Institute
Barcelona Centre for International Health Research
Investigators
Principal Investigator: Ivo Mueller, PhD Walter and Eliza Hall Institute of Medical Research; Centre de Recerca en Salut Internacional de Barcelona (CRESIB)
Principal Investigator: Inoni Betuela, MD PhD PNG Institute of Medical Research
Principal Investigator: Louis Schofield, PhD Walter and Eliza Hall Institute of Medical Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier: NCT02143934     History of Changes
Other Study ID Numbers: 07200734
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by Papua New Guinea Institute of Medical Research:
Plasmodium vivax
Hypnozoites
Primaquine
Liver-stage
Blood-stage
Plasmodium falciparum

Additional relevant MeSH terms:
Infection
Communicable Diseases
Malaria
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Lumefantrine
Artemether
Primaquine
Artemether-lumefantrine combination
Artemisinins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Antifungal Agents
Coccidiostats