Status:
COMPLETED
Dihydroartemisinin-piperaquine With Low Dose Primaquine to Reduce Malaria Transmission
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Radboud University Medical Center
International Centre of Insect Physiology and Ecology (ICIPE)
Conditions:
Malaria
Asymptomatic Malaria
Eligibility:
All Genders
5-15 years
Phase:
PHASE3
Brief Summary
Primaquine (PQ) is currently the only available drug that can clear the mature transmission stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist after artemisin...
Eligibility Criteria
Inclusion
- Microscopically detectable P. falciparum gametocyte carriage
Exclusion
- Age \< 5 years or \> 15 years
- Non-falciparum malaria co-infection
- Malaria parasite density ≥ 200,000 parasites/µL
- Clinical symptoms indicating severe malaria
- Axillary temperature ≥ 39°C
- Body Mass Index (BMI) below 16 or above 32 kg/m2
- Haemoglobin concentration below 9.5 g/dL
- Anti-malarials taken in last 2 days
- For women: Pregnancy (assessed by clinical examination and urine pregnancy test) or lactation
- Known hypersensitivity to DP or PQ
- History and/or symptoms indicating chronic illness
- Current use of tuberculosis or anti-retroviral medication
- Unable to give written informed consent
- Unwillingness to participate in two membrane feeding assays
- Travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, - Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan
- Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
- Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride
- Known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia
- Taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine)
- Blood transfusion within last 90 days
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02259426
Start Date
October 1 2014
End Date
December 1 2015
Last Update
January 14 2016
Active Locations (1)
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1
ICIPE
Mbita, Nyanza, Kenya, 30-40305