NCT01906788

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Kilimanjaro Clinical Research Institute · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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"

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.

Conditions

• Malaria Transmission

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-07-24
• Last updated: 2013-07-24

Locations

1 site across 1 country: Tanzania