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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malaria Malaria, Falciparum | Drug: MDA with DHAp (Eurartesim) Drug: Focal MDA with DHAp (Eurartesim) | Not Applicable |

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 |

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.
|
- 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)
- 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
- 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
- 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)
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Zambia | |
Southern province medical office | |
Choma, Southern, Zambia |
Principal Investigator: | John M Miller, PhD | PATH |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
malaria malaria, falciparum antimalarials |
Malaria Malaria, Falciparum Protozoan Infections |
Parasitic Diseases Infections Vector Borne Diseases |