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

NCT02329301 | Completed DMC

• 1 other identifier: PATH-WIRB-20140824
• Study Type: interventional
• Target: 2,430
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Malaria, Falciparum

Keywords

malaria; malaria, falciparum; antimalarials

Outcome Measures

Primary Outcomes (2)

• Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)

  Parasite prevalence during the high transmission season among children \<6 years old (excluding neonates \<1 month)

  For up to 12 months

• P.falciparum infection incidence rate among individuals ≥3 months

  P.falciparum infection incidence rate among individuals ≥3 months

  For up to 12 months

Secondary Outcomes (2)

• Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages

  For up to 48 months (including retrospectively)

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

  For up to 10 months

Other Outcomes (1)

• Population coverage of the fMDA and MDA interventions at each round

  For up to 4 months

Study Arms (3)

MDA with DHAp (Eurartesim)

EXPERIMENTAL

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)

Focal MDA with DHAp (Eurartesim)

EXPERIMENTAL

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)

Standard of Care (Control)

NO INTERVENTION

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.

Interventions

MDA with DHAp (Eurartesim) DRUG

Eurartesim is the brand name.

Also known as: mass drug administration with DHAp

MDA with DHAp (Eurartesim)

Focal MDA with DHAp (Eurartesim) DRUG

Eurartesim is the brand name.

Also known as: focal mass drug administration with DHAp

Focal MDA with DHAp (Eurartesim)

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• anyone not excluded and consenting

You may not qualify if:

• 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

Sponsors & Collaborators

• PATH: lead
• Ministry of Health, Zambia: collaborator
• Minister of Community Development, Mother and Child Health, Zambia: collaborator
• Tulane University: collaborator

Study Sites (1)

Southern province medical office

Choma, Southern Province, Zambia

Location

Related Publications (12)

• Eisele TP, Silumbe K, Finn T, Chalwe V, Kamuliwo M, Hamainza B, Moonga H, Bennett A, Yukich J, Keating J, Steketee RW, Miller JM. Assessing the effectiveness of household-level focal mass drug administration and community-wide mass drug administration for reducing malaria parasite infection prevalence and incidence in Southern Province, Zambia: study protocol for a community randomized controlled trial. Trials. 2015 Aug 13;16:347. doi: 10.1186/s13063-015-0862-3.

  PMID: 26268804 BACKGROUND

• Eisele TP, Bennett A, Silumbe K, Finn TP, Chalwe V, Kamuliwo M, Hamainza B, Moonga H, Kooma E, Chizema Kawesha E, Yukich J, Keating J, Porter T, Conner RO, Earle D, Steketee RW, Miller JM. Short-term Impact of Mass Drug Administration With Dihydroartemisinin Plus Piperaquine on Malaria in Southern Province Zambia: A Cluster-Randomized Controlled Trial. J Infect Dis. 2016 Dec 15;214(12):1831-1839. doi: 10.1093/infdis/jiw416.

  PMID: 27923947 BACKGROUND

• Alonso PL. The Role of Mass Drug Administration of Antimalarials. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):1-2. doi: 10.4269/ajtmh.20-0729. No abstract available.

  PMID: 32618264 BACKGROUND

• Eisele TP, Bennett A, Silumbe K, Finn TP, Porter TR, Chalwe V, Hamainza B, Moonga H, Kooma E, Chizema Kawesha E, Kamuliwo M, Yukich JO, Keating J, Schneider K, Conner RO, Earle D, Slutsker L, Steketee RW, Miller JM. Impact of Four Rounds of Mass Drug Administration with Dihydroartemisinin-Piperaquine Implemented in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):7-18. doi: 10.4269/ajtmh.19-0659.

  PMID: 32618247 BACKGROUND

• Yukich JO, Scott C, Silumbe K, Larson BA, Bennett A, Finn TP, Hamainza B, Conner RO, Porter TR, Keating J, Steketee RW, Eisele TP, Miller JM. Cost-Effectiveness of Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine for Malaria Prevention in Southern Province, Zambia: Results of a Community-Randomized Controlled Trial. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):46-53. doi: 10.4269/ajtmh.19-0661.

  PMID: 32618249 BACKGROUND

• Finn TP, Porter TR, Moonga H, Silumbe K, Daniels RF, Volkman SK, Yukich JO, Keating J, Bennett A, Steketee RW, Miller JM, Eisele TP. Adherence to Mass Drug Administration with Dihydroartemisinin-Piperaquine and Plasmodium falciparum Clearance in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):37-45. doi: 10.4269/ajtmh.19-0667.

  PMID: 32618267 BACKGROUND

• Finn TP, Yukich JO, Bennett A, Porter TR, Lungu C, Hamainza B, Chizema Kawesha E, Conner RO, Silumbe K, Steketee RW, Miller JM, Keating J, Eisele TP. Treatment Coverage Estimation for Mass Drug Administration for Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):19-27. doi: 10.4269/ajtmh.19-0665.

  PMID: 32618251 BACKGROUND

• Silumbe K, Finn TP, Jennings T, Sikombe C, Chiyende E, Hamainza B, Chizema Kawesha E, Eisele TP, Earle D, Steketee RW, Miller JM. Assessment of the Acceptability of Testing and Treatment during a Mass Drug Administration Trial for Malaria in Zambia Using Mixed Methods. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):28-36. doi: 10.4269/ajtmh.19-0663.

  PMID: 32618242 BACKGROUND

• Miller JM, Eisele TP, Fraser MS, Lewis MT, Slutsker L, Chizema Kawesha E. Moving from Malaria Burden Reduction toward Elimination: An Evaluation of Mass Drug Administration in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):3-6. doi: 10.4269/ajtmh.19-0669.

  PMID: 32618265 BACKGROUND

• Bennett A, Porter TR, Mwenda MC, Yukich JO, Finn TP, Lungu C, Silumbe K, Mambwe B, Chishimba S, Mulube C, Bridges DJ, Hamainza B, Slutsker L, Steketee RW, Miller JM, Eisele TP. A Longitudinal Cohort to Monitor Malaria Infection Incidence during Mass Drug Administration in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):54-65. doi: 10.4269/ajtmh.19-0657.

  PMID: 32618245 BACKGROUND

• Chishimba S, Mwenda M, Mambwe B, Mulube C, Chalwe V, Moonga H, Hamainza B, Chizema-Kawesha E, Steketee RW, Domingo G, Fraser M, Kahn M, Pal S, Silumbe K, Conner RO, Bennett A, Porter TR, Eisele TP, Miller JM, Bridges DJ. Prevalence of Plasmodium falciparum and Non-falciparum Infections by Photo-Induced Electron Transfer-PCR in a Longitudinal Cohort of Individuals Enrolled in a Mass Drug Administration Trial in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):82-89. doi: 10.4269/ajtmh.19-0668.

  PMID: 32618252 BACKGROUND

• Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.

  PMID: 34585740 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Mass Drug Administration

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Disease Eradication; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice

Study Officials

• John M Miller, PhD

  PATH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: December 31, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

ZA (1)