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
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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|
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
- 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.
- 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
- 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.
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
|Contact: Seif Shekalaghe, MD, PhD||+255 755 email@example.com|
|Bagamoyo Research and Training Centre||Recruiting|
|Contact: Seif Shekalaghe, MD, PhD +255 755 470472 firstname.lastname@example.org|
|Sub-Investigator: Chris Drakeley, PhD|
|Sub-Investigator: Teun Bousema, PhD|
|Sub-Investigator: Salim Abdulla, MD, PhD|
|Principal Investigator:||Seif Shekalaghe, MD, PhD||Kilimanjaro Clinical Research Institute and Ifakara Health Institute|