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The Optimal Timing Of Primaquine To Prevent Malaria Transmission After Artemisinin-Combination Therapy

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ClinicalTrials.gov Identifier: NCT01906788
Recruitment Status : Unknown
Verified July 2013 by Kilimanjaro Clinical Research Institute.
Recruitment status was:  Recruiting
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Ifakara Health Institute
Information provided by (Responsible Party):
Kilimanjaro Clinical Research Institute

Brief Summary:
The investigators' Hypothesis is that "The correct timing of gametocytocidal drug in combination with an effective Artemisinin Combination Therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment"

Condition or disease Intervention/treatment Phase
Malaria Transmission Drug: Artemether Lumefantrine Drug: Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0 Drug: Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2 Phase 4

Detailed Description:

Global malaria elimination is back on the agenda, gametocytocidal drugs such as primaquine are currently advocated for use in the interventions that aim to interrupt malaria transmission and hence elimination. Mature gametocytes are responsible for malaria transmission. Artemisinin based combination therapies (ACTs) has limited effect on the young gametocytes. Primaquine is able to clear mature gametocytes that remain after treatment with ACTs. Complete clearance of mature gametocytes will depend on the ideal time primaquine is given after ACT. It is important therefore that is administered at optimal time in order to have significant impact on clearing gametocytes to interrupt malaria transmission. An additional consideration is operational administration of Primaquine and compliance both of which are likely to be enhanced if the drug is administered on the day of diagnosis.

In this study, the investigators aim to determine optimal timing of primaquine administration in addition to ACT by comparing administration on day 0 with administration on day 2.

The investigators' primary end points are gametocyte prevalence and density by microscopy and Quantitative Nucleic Acid Based Amplification (QT-NASBA) on day 14, which will be compared between the two primaquine treatment arms.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: THE OPTIMAL TIMING OF PRIMAQUINE TO PREVENT MALARIA TRANSMISSION AFTER ARTEMISININ-COMBINATION THERAPY
Study Start Date : May 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Group 1
Active comparator: Artemether Lumefantrine 6 dose regime orally
Drug: Artemether Lumefantrine
Experimental: Group 2
Experimental: Artemether Lumefantrine 6 dose regime Plus single dose Primaquine (0.75/kg) on day 0
Drug: Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0
Experimental: Group 3
Experimental: Artemether Lumefantrine 6 dose regimen plus single dose of Primaquine (0.75/kg) on day 2
Drug: Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2



Primary Outcome Measures :
  1. Gametocyte prevalence and density by microscopy and QT-NASBA [ Time Frame: Day 14 ]
    By microscopy and QT-NASBA techniques we will determine and compare gametocyte prevalence and density on day 14 between the Primaquine treatment 2 and 3 arms.


Secondary Outcome Measures :
  1. Haemoglobin level [ Time Frame: days 3, 7, 10 and 14 ]
    We will compare the level of baseline haemoglobin on days 3, 7, 10 and 14 after the start of treatment between the two Primaquine arms


Other Outcome Measures:
  1. Proportion of infected mosquitoes [ Time Frame: day 7 ]
    We will determine the proportion of infected mosquitoes on day 7 after initiation of treatment and the intensity of infection (oocyst burden)by use of membrane feeding assay technique.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 3 years - 17 years
  • Residents of research area
  • Willingness to come for complete scheduled follow-up.
  • Uncomplicated malaria with P. falciparum mono-infection
  • Axillary temperature > 37.5°C and < 39.5°C, or history of fever in previous 48 hours.
  • No history of adverse reactions to study medication
  • Understanding of the procedures of the study by parent or guardian and willing to participate by signing written informed consent forms

Exclusion Criteria:

  • Haemoglobin below 9g/dl
  • Inability to take drugs orally
  • Known hypersensitivity to any of the drugs given
  • Reported treatment with antimalarial chemotherapy in the past 2 weeks
  • Evidence of chronic disease or acute infection other than malaria
  • Domicile outside the study area
  • Signs of severe malaria( such as respiratory distress, altered consciousness deep breathing, anaemia)
  • Participating in other malaria studies conducted in the region
  • Mixed malaria parasite species infection
  • Positive pregnant test by Urine (UPT) if participant is female aged above 12 years
  • G6PD deficient using the fluorescence spot test

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): NCT01906788


Contacts
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Contact: Seif Shekalaghe, MD, PhD +255 755 470472 sshekalaghe@ihi.or.tz

Locations
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Tanzania
Bagamoyo Research and Training Centre Recruiting
Bagamoyo, Tanzania
Contact: Seif Shekalaghe, MD, PhD    +255 755 470472    sshekalaghe@ihi.or.tz   
Sub-Investigator: Chris Drakeley, PhD         
Sub-Investigator: Teun Bousema, PhD         
Sub-Investigator: Salim Abdulla, MD, PhD         
Sponsors and Collaborators
Kilimanjaro Clinical Research Institute
London School of Hygiene and Tropical Medicine
Ifakara Health Institute
Investigators
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Principal Investigator: Seif Shekalaghe, MD, PhD Kilimanjaro Clinical Research Institute and Ifakara Health Institute

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Responsible Party: Kilimanjaro Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01906788     History of Changes
Other Study ID Numbers: PRIMAQUINE STUDY
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Primaquine
Artemether, Lumefantrine Drug Combination
Artemisinins
Artemisinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents