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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02329301 |
Date of registration:
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13/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia
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Scientific title:
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Assessing the Effectiveness of Mass Drug Administration (MDA) With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia |
Date of first enrolment:
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September 2014 |
Target sample size:
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2430 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02329301 |
Study type:
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Interventional |
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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N/A
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Countries of recruitment
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Zambia
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Contacts
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Name:
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John M Miller, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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PATH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- anyone not excluded and consenting
Exclusion Criteria:
- contraindications from manufacturer for medications including currently taking
haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin,
Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis),
lumefantrine (in Coartem), quinine, Septrin
- anyone seriously ill
- currently taking antimalarial medicines
- allergy to artemisinin drugs
- pregnant women in first trimester
- children under 3 months of age
- reported heart condition
Age minimum:
3 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria, Falciparum
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Malaria
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Intervention(s)
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Drug: Focal MDA with DHAp (Eurartesim)
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Drug: MDA with DHAp (Eurartesim)
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Primary Outcome(s)
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Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)
[Time Frame: For up to 12 months]
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P.falciparum infection incidence rate among individuals =3 months
[Time Frame: For up to 12 months]
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Secondary Outcome(s)
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Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group)
[Time Frame: For up to 10 months]
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Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
[Time Frame: For up to 48 months (including retrospectively)]
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Secondary ID(s)
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PATH-WIRB-20140824
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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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