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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01838902 |
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Date of registration:
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12/04/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers
PRINOGAM |
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Scientific title:
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Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers Treated With Dihydroartemisinin-piperaquine in The Gambia |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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467 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01838902 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Umberto D'Alessandro, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MRC Unit, Fajara The Gambia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Age =1 year
- Weight >10 Kg
- P. falciparum mono-infection, density of at least 20 parasites/µL
- Axillary temperature < 37.5ºC
- Resident in the study area and willingness to reside for the duration of the study
- Written informed consent (plus an assent in children >12years of age)
Exclusion Criteria:
- G6PD Deficiency Haemoglobin <8g/dl
- Known allergy to any of the study medications
- Known Pregnancy or breastfeeding
- Clear/documented history of anti-malarial treatment 2 weeks before contact with
study team
- History of blood transfusion in the previous 3 months
- Any chronic or acute conditions that might interfere with the study as judged by
the research clinician
- History of sickle cell anaemia
Age minimum:
12 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: PQ (0.4)
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Drug: PQ (0.75)
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Drug: DHA-PPQ
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Drug: PQ (0.2)
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Primary Outcome(s)
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Prevalence of P. falciparum gametocyte carriers (QT-NASBA)
[Time Frame: Day 7]
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Secondary Outcome(s)
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Proportion of individuals infectious to mosquitoes (DMFA)
[Time Frame: Day 7]
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Haemoglobin change
[Time Frame: Day 0 and days 3, 7, 10, 14, 21, 28, 35 and 42]
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Prevalence of infection (asexual stages)
[Time Frame: Day 3]
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Occurrence of adverse events (AEs) and serious adverse events (SAEs)
[Time Frame: Day 3 to Day 42]
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Prevalence of P.Falciparum gametocytes carriers
[Time Frame: Days 3, 10, 14, 28 and 42]
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Proportion of participants with recurrent infection (PCR adjusted and unadjusted)
[Time Frame: Day 7 to Day 42]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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