Dihydroartemisinin-piperaquine for Seasonal Malaria Chemoprophylaxis in Tanzania

NCT05874869 | Completed DMC

• 1 other identifier: MUHAS-REC-10-2019-062
• Study Type: interventional
• Target: 13,800
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Malaria prevalence has declined globally following the scale-up of the interventions, including insecticide-treated bed-net, indoor residual spraying, and prompt diagnosis and treatment with artemisinin-based combination therapy (ACT). Despite the gained success in the control, malaria has remained a major public health problem, particularly affecting children aged \< 5 years in sub-Saharan Africa. Most of the malaria transmissions occur during the rainy season, a relatively short period. Intervention using antimalarial chemotherapy in children during the transmission season has been shown to prevent malaria-related morbidity and mortality. The World Health Organization has recommended seasonal malaria chemoprevention (SMC) using Sulphadoxine-pyrimethamine (SP) plus amodiaquine (AQ) in children aged 3-59 months in areas with highly seasonal malaria transmission. However, SP-AQ resistance is widespread in Tanzania. Therefore, this study will assess the effectiveness of Dihydroartemisinin-piperaquine (DHA-PQ) as SMC for the control of malaria among children in Tanzania. Methods: Afebrile children aged 3-59 months from Nanyumbu and Masasi districts in the Mtwara region will be enrolled in an open cluster randomized clinical trial, administered monthly with a full course of DHA-PQ for three or four consecutive months during the high malaria transmission season of the three consecutive years. Three approaches of DHA-PQ SMC administration will be tested; a door-to-door approach using community health workers (CHWs), outreach visits using local health facilities clinicians/nurses, and village health posts using selected CHWs. Study participants will then be followed-up to evaluate the impact of the intervention on all-course of malaria morbidity and mortality; adverse events associated with the intervention; acceptability, adherence, coverage, and cost-effectiveness of the intervention; treatment-seeking behavior; and the risk of rebound after the withdrawal of the intervention. The primary outcome will be a prevalence of clinical malaria defined as the presence of fever (axillary temperature of 37.5 degrees Celsius) or a history of fever in the past 24 hours and the presence of P. falciparum asexual parasitemia at any density. Findings: The findings will be disseminated through community meetings, seminars, local and international conferences, and publication in international journals. Impact: The findings from this study will provide information on the effectiveness of DHA-PQ for seasonal prevention of malaria morbidity and mortality in children aged \< 5 years in Tanzania.

Conditions

Malaria; Chemoprophylaxis; Underfive Children

Outcome Measures

Primary Outcomes (1)

• Prevalence of clinical malaria

  Defined as the presence of any malaria-related signs/symptoms plus P. falciparum asexual parasitemia at any density. For it to be considered a clinical malaria there must be any signs or symptoms related to malaria infection and the presence of asexual P. falciparum parasites confirmed by mRDT or microscopy.

  12 months

Secondary Outcomes (7)

• Incidence of severe malaria

  12 months

• Prevalence of malaria infection

  12 months

• Prevalence of anaemia

  12 months

• Prevalence of hospital admissions

  12 months

• Prevalence of participants with any anthropometric indices.

  12 months

Study Arms (2)

Dihydroartemisinin-piperaquine

ACTIVE COMPARATOR

Dihydroartemisinin-piperaquine will be administered to the intervention arm

Drug: Dihydroartemisinin-piperaquine

Control

NO INTERVENTION

Individuals that will get malaria infection and present at the health facility with clinical signs and symptoms will be treated according to the Tanzania National Malaria Treatment guidelines using artemether-lumefantrine.

Interventions

Dihydroartemisinin-piperaquine DRUG

The drug will be administered once a day for three consecutive days for three months (March, April, and May)

Dihydroartemisinin-piperaquine

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• being afebrile,
• willing to participate in the trial, and
• the ability to swallow oral medications.

You may not qualify if:

• a presence of an acute febrile illness or severe illness that impairs the ability to take oral medication
• HIV-positive child receiving cotrimoxazole prophylaxis,
• a child who has received a dose of antimalarial drug including dihydroartemisinin-piperaquine during the past month; and
• a history of allergy to DHA-PQ.

Sponsors & Collaborators

• Richard Mwaiswelo: lead
• Muhimbili University of Health and Allied Sciences: collaborator
• National Institute for Medical Research, Tanzania: collaborator
• Hubert Kairuki Memorial University: collaborator

Study Sites (1)

Muhimbili University of Health and Allied Ssciences

Dar es Salaam, 65001, Tanzania

Location

Related Publications (1)

• Mwaiswelo R, Ngasala B, Chaky F, Molteni F, Mohamed A, Lazaro S, Samwel B, Mmbando BP. Dihydroartemisinin-piperaquine effectiveness for seasonal malaria chemoprevention in settings with extended seasonal malaria transmission in Tanzania. Sci Rep. 2024 Jan 25;14(1):2143. doi: 10.1038/s41598-024-52706-z.

  PMID: 38273019 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 25, 2023
• Study Start: July 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months
• Access Criteria: Request to the PI

Locations

TA (1)