The Optimal Timing Of Primaquine To Prevent Malaria Transmission After Artemisinin-Combination Therapy
THE OPTIMAL TIMING OF PRIMAQUINE TO PREVENT MALARIA TRANSMISSION AFTER ARTEMISININ-COMBINATION THERAPY
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Bagamoyo, Tanzania
- Recruiting
- Bagamoyo Research and Training Centre
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Contact:
- Seif Shekalaghe, MD, PhD
- Phone Number: +255 755 470472
- Email: sshekalaghe@ihi.or.tz
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Sub-Investigator:
- Chris Drakeley, PhD
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Sub-Investigator:
- Teun Bousema, PhD
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Sub-Investigator:
- Salim Abdulla, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Group 1
Active comparator: Artemether Lumefantrine 6 dose regime orally
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EXPERIMENTAL: Group 2
Experimental: Artemether Lumefantrine 6 dose regime Plus single dose Primaquine (0.75/kg) on day 0
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EXPERIMENTAL: Group 3
Experimental: Artemether Lumefantrine 6 dose regimen plus single dose of Primaquine (0.75/kg) on day 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gametocyte prevalence and density by microscopy and QT-NASBA
Time Frame: Day 14
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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.
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Day 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Haemoglobin level
Time Frame: days 3, 7, 10 and 14
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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
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days 3, 7, 10 and 14
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of infected mosquitoes
Time Frame: day 7
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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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day 7
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Collaborators and Investigators
Investigators
- Principal Investigator: Seif Shekalaghe, MD, PhD, Kilimanjaro Clinical Research Institute and Ifakara Health Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRIMAQUINE STUDY
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