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Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes

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ClinicalTrials.gov Identifier: NCT02090036
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Richard Mwaiswelo, Muhimbili University of Health and Allied Sciences

Brief Summary:
The purpose of this study is to assess efficacy and safety of a single low-dose Primaquine added to standard artemether/lumefantrine treatment for the clearance of Plasmodium falciparum gametocytes among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status.

Condition or disease Intervention/treatment Phase
Plasmodium Falciparum Drug: Primaquine (For artemether-lumefantrine+primaquine arm) Drug: Placebo (For artemether-lumefantrine arm) Phase 4

Detailed Description:

The current gained successes in malaria control are accredited partly to the availability of efficacious and fast acting artemisinins which are also potent against P. falciparum young gametocytes. Nonetheless, mature gametocytes may persist after treatment, contributing to malaria transmission. Conversely, artemisinin resistance is confirmed in South-east Asia, and it may spread to Africa. New control tools have to be integrated to sustain the gained successes, further reduce transmission and curb the spread of resistance.

Primaquine has strong gametocytocidal effect against mature gametocytes and when added to schizonticidal drugs such as artemether-lumefantrine (AL), it rapidly shorten gametocytes carriage duration, halting disease transmission. Nonetheless, its wide scale use has been hampered by a dose-dependent acute hemolytic anemia it causes in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. Conversely, Artemisinins potentiate primaquine activities, thus a low dose of primaquine would be able to clear falciparum gametocytes.

The World Health Organization recommends addition of 0.25 mg/kg single-dose primaquine to Artemisinin based combination therapies in malaria endemic areas including Africa without testing for G6PD status. Nonetheless, the recommendation, relies on historical data from South-East Asia and among African Americans in the United States. Therefore, this study plans to assess safety and efficacy of 0.25 mg/kg single-dose primaquine added to a standard AL treatment against P. falciparum gametocytes clearance among patients with uncomplicated malaria aged 1 year and above regardless of their G6PD status..

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of a Single Low-dose Primaquine Added to Standard Artemether-lumefantrine Treatment for the Clearance of Plasmodium Falciparum Gametocytes.
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: artemether-lumefantrine+placebo
In the artemether-lumefantrine arm, the first dose of artemether-lumefantrine will be administered concomitantly with a single-dose placebo. A volume of normal saline will be measured based on weight bands and then will be given to patients.
Drug: Placebo (For artemether-lumefantrine arm)
Volume of normal saline mixed with coloured fruit juice measured based on weight bands will be given orally concomitantly with first dose of artemether-lumefantrine.

Experimental: artemether-lumefantrine+primaquine
All the recruited patients will be treated with a six doses, 3 days artemether-lumefantrine treatment regimen. However, patients randomized to the artemether-lumefantrine+primaquine arm will be given 0.25 mg/kg single-dose primaquine concomitantly with artemether-lumefantrine first dose.
Drug: Primaquine (For artemether-lumefantrine+primaquine arm)
A 0.25 mg/kg single-dose primaquine will be administered concomitantly with the first dose of artemether-lumefantrine in all patients randomized into the artemether-lumefantrine+primaquine arm.




Primary Outcome Measures :
  1. Number of days per treatment arm for gametocytes to become undetectable using Quantitative nucleic acid sequence based assay (QT-NASBA). [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Mean maximal fall in hemoglobin (g/dl) from enrolment to day 28 of follow-up defined as mean greatest negative difference in hemoglobin per treatment arm. [ Time Frame: 28 days. ]

Other Outcome Measures:
  1. Proportion of patients with urine color change score ≥ 5 using Hillmen Urine Colour Chart, per treatment arm. [ Time Frame: 28 days. ]


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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:

  • Age of 1 year and above and neither pregnant nor breast feeding.
  • Weight over 10 kg.
  • Body temperature ≥37.5°C) or history of fever in the last 24 hours.
  • P. falciparum mono-infection.

Exclusion Criteria:

  • Evidence of severe illness malaria or danger signs.
  • Known allergy to study medications.
  • Hemoglobin <8 g/dl.
  • Antimalarials taken within last 2 weeks.
  • Blood transfusion within last 90 days and evidence of recent use (within 14 days)of or will be taking other drugs known to cause hemolysis in G6PD deficient subjects.

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): NCT02090036


Locations
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Tanzania
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania, 65001
Sponsors and Collaborators
Muhimbili University of Health and Allied Sciences
Karolinska Institutet
Investigators
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Study Director: Andreas Martensson, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Mwaiswelo, Investigator, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier: NCT02090036    
Other Study ID Numbers: 1.0.2014
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Richard Mwaiswelo, Muhimbili University of Health and Allied Sciences:
Efficacy
Safety
Primaquine
Artemether-lumefantrine
Gametocytes
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Primaquine
Artemether, Lumefantrine Drug Combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents