The Optimal Timing Of Primaquine To Prevent Malaria Transmission After Artemisinin-Combination Therapy
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Gametocyte prevalence and density by microscopy and QT-NASBA [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
- Haemoglobin level [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
- Proportion of infected mosquitoes [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 3 years - 17 years
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Residents of research area
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Willingness to come for complete scheduled follow-up.
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Uncomplicated malaria with P. falciparum mono-infection
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Axillary temperature > 37.5°C and < 39.5°C, or history of fever in previous 48 hours.
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No history of adverse reactions to study medication
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Understanding of the procedures of the study by parent or guardian and willing to participate by signing written informed consent forms
Exclusion Criteria:
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Haemoglobin below 9g/dl
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Inability to take drugs orally
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Known hypersensitivity to any of the drugs given
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Reported treatment with antimalarial chemotherapy in the past 2 weeks
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Evidence of chronic disease or acute infection other than malaria
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Domicile outside the study area
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Signs of severe malaria( such as respiratory distress, altered consciousness deep breathing, anaemia)
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Participating in other malaria studies conducted in the region
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Mixed malaria parasite species infection
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Positive pregnant test by Urine (UPT) if participant is female aged above 12 years
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G6PD deficient using the fluorescence spot test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bagamoyo Research and Training Centre | Bagamoyo | Tanzania |
Sponsors and Collaborators
- Kilimanjaro Clinical Research Institute
- London School of Hygiene and Tropical Medicine
- Ifakara Health Institute
Investigators
- Principal Investigator: Seif Shekalaghe, MD, PhD, Kilimanjaro Clinical Research Institute and Ifakara Health Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRIMAQUINE STUDY