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Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329301
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Ministry of Health, Zambia
Minister of Community Development, Mother and Child Health, Zambia
Tulane University
Information provided by (Responsible Party):
PATH

Brief Summary:
To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD malaria case incidence and cohort infection incidence in areas of high and low malaria transmission and in a program-relevant manner that will permit adoption and adaptation for wider-scale deployment.

Condition or disease Intervention/treatment Phase
Malaria Malaria, Falciparum Drug: MDA with DHAp (Eurartesim) Drug: Focal MDA with DHAp (Eurartesim) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Effectiveness of Mass Drug Administration (MDA) With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia
Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: MDA with DHAp (Eurartesim)
All consenting community members eligible to receive DHAp will be provided age-appropriate treatment dose of DHAp regardless of the malaria rapid diagnostic test (RDT) result. Treatment will be administered in a house-to-house campaign.
Drug: MDA with DHAp (Eurartesim)
Eurartesim is the brand name.
Other Name: mass drug administration with DHAp

Experimental: Focal MDA with DHAp (Eurartesim)
All consenting household members eligible to receive DHAp and living in a household where anyone in the household tests positive with a malaria rapid diagnostic test (RDT) will receive the age-appropriate treatment dose of DHAp. If no one in the household tests RDT positive then no one in the household will receive DHAp. Treatment will be administered in a house-to-house campaign.
Drug: Focal MDA with DHAp (Eurartesim)
Eurartesim is the brand name.
Other Name: focal mass drug administration with DHAp

No Intervention: Standard of Care (Control)
The standard of care arm will reflect no community-based treatment interventions but will have the standard of care offered by the Ministry of Health and Ministry of Community Development, Mother and Child Health which applies to all arms. This includes available mosquito net coverage, indoor residual spraying and passive case detection of individuals seeking treatment from a health provider at a clinic or health post.



Primary Outcome Measures :
  1. Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) [ Time Frame: For up to 12 months ]
    Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)

  2. P.falciparum infection incidence rate among individuals ≥3 months [ Time Frame: For up to 12 months ]
    P.falciparum infection incidence rate among individuals ≥3 months


Secondary Outcome Measures :
  1. 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) ]
    Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages

  2. 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 ]
    Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group)


Other Outcome Measures:
  1. Population coverage of the fMDA and MDA interventions at each round [ Time Frame: For up to 4 months ]
    Population coverage of the fMDA and MDA interventions at each round



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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02329301


Locations
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Zambia
Southern province medical office
Choma, Southern, Zambia
Sponsors and Collaborators
PATH
Ministry of Health, Zambia
Minister of Community Development, Mother and Child Health, Zambia
Tulane University
Investigators
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Principal Investigator: John M Miller, PhD PATH
Publications:

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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02329301    
Other Study ID Numbers: PATH-WIRB-20140824
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Keywords provided by PATH:
malaria
malaria, falciparum
antimalarials
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases