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Trial record 7 of 11 for:    Malaria | Ethiopia

Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas (PRIMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916003
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Tribhuvan University, Nepal
Arba Minch University, Ethiopia
Information provided by (Responsible Party):
Menzies School of Health Research

Brief Summary:

Plasmodium vivax forms dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a 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 (1.0 mg/kg/day for 7 days) with a 14 day regimen (0.5 mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5-fold more efficacious at reducing P. vivax recurrence than the control.

This study is designed as a multicentre randomized, open label trial to compare the safety and efficacy of a high dose PQ treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practise of providing only schizontocidal treatment.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial
Actual Study Start Date : August 18, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: PQ7
high dose Primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)
Drug: primaquine
Primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)

No Intervention: standard care



Primary Outcome Measures :
  1. incidence risk of symptomatic P. vivax malaria at day 63 [ Time Frame: 63 days ]
    The incidence risk of symptomatic P. vivax malaria at day 63 in patients enrolled with P. falciparum malaria infection treated with AL (control group in Ethiopia, Bangladesh and Nepal) and AL plus PQ (intervention group)


Secondary Outcome Measures :
  1. incidence risk of symptomatic P. vivax malaria at day 28 and day 42 [ Time Frame: day 28/42 ]
  2. incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28, 42 and 63 [ Time Frame: day 28/42/63 ]
  3. incidence risk of asymptomatic P. vivax malaria at day 28, 42 and 63 [ Time Frame: day 28/42/63 ]
  4. incidence risk of asymptomatic P. falciparum malaria at day 28, 42 and 63 [ Time Frame: day 28/42/63 ]
  5. proportion of patients vomiting their medication within 1 hour of administration [ Time Frame: 1 hour ]
  6. proportion of patients vomiting any of their PQ doses during the 7 day supervised course [ Time Frame: 7 days ]
  7. proportion of adverse events and serious adverse events [ Time Frame: 63 days ]
  8. incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion [ Time Frame: 63 days ]
  9. Risk of greater than 25% fall in haemoglobin on day 2 or day7 [ Time Frame: day 2/7 ]
  10. incidence risk of an acute drop in Hb of >5g/dl within 7 days of starting PQ treatment [ Time Frame: day 7 ]


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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 mono-infection
  • Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
  • Age >1 years
  • G6PD normal as defined by the Biosensor (SD Bioline, ROK) at ≥70% of the adjusted male median (AMM) for each site
  • 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): NCT03916003


Contacts
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Contact: Kamala Thriemer +61889468644 kamala.ley-thriemer@menzies.edu.au

Locations
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Bangladesh
Icddrb Recruiting
Alikadam, Bangladesh
Contact: Shafiul Alam, PhD         
Ethiopia
Arba Minch University Not yet recruiting
Arba Minch, Ethiopia
Indonesia
Not yet recruiting
Sumba, Indonesia
Sponsors and Collaborators
Menzies School of Health Research
International Centre for Diarrhoeal Disease Research, Bangladesh
Tribhuvan University, Nepal
Arba Minch University, Ethiopia
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Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT03916003    
Other Study ID Numbers: 19-3288
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Protozoan Infections
Parasitic Diseases
Primaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents