Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique

NCT06337253 | Not Yet Recruiting Phase 4

• 1 other identifier: MOZ202401
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique. The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention. These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region.

Conditions

Malaria,Falciparum; Chemoprevention

Outcome Measures

Primary Outcomes (1)

• Chemoprevention failure

  A positive qPCR for P. falciparum parasites on day 28 after SP+AQ administration or P. falciparum positive slides at any time from day 7

  42 days

Secondary Outcomes (1)

• Uncomplicated malaria within 28 days

  28 days

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention in this study is the administration of one cycle of SPAQ medicines. SPAQ medicines procured by Malaria Consortium are from Tridem Pharma, one of the three manufacturers with WHO prequalification, with whom Malaria Consortium has framework agreements. Each monthly SMC cycle consists of one dispersible tablet of SP and three daily dispersible tablets of AQ. There are two doses of SPAQ: a lower dose for children aged 3-12 months, and a higher dose for children aged 12 to 59 months. For children aged 12 to 59 months, the dosage comprises a single dose of a full tablet of SP 500/25mg and three daily doses of a full tablet of AQ 153mg. Those aged 3-12 months are administered half the dose given to those aged 12 to 59 months, given as full dispersible tablets.

Drug: Sulfadoxine/pyrimethamine plus amodiaquine

Interventions

Sulfadoxine/pyrimethamine plus amodiaquine DRUG

Seasonal Malaria Chemoprevention with SPAQ has not been trialed or introduced in Malawi yet. This intervention trial is different from others because of the location and because, traditionally, a full round of SMC with SPAQ that involves between 3-5 cycles is administered. Our trial is the first one that will only distribute one cycle of SMC with SPAQ. The data collected during the 42 days after SMC distribution will be used to estimate the medicines chemoprevention effectiveness at preventing malaria in children aged 3-59 months. This data, together with the resistance markers data will then be fed into a dynamical model that collaborators at Imperial College London have developed that will predic the potential impact of upscaling SMC in similar geographies.

Also known as: SPAQ

Intervention

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Within 3 to 59 months
• Parents have provided written consent

You may not qualify if:

• Outside 3 to 59 months or age
• Parents have not provided written consent

Sponsors & Collaborators

• Malaria Consortium: lead

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Sulfadoxine; Pyrimethamine; Amodiaquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sam Gudoi

  Malaria Consortium

  STUDY DIRECTOR

Central Study Contacts

Kevin Baker

CONTACT

07811266539; k.baker@malariaconsortium.org

Maria Suau Sans

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention in this study is the administration of one cycle of SPAQ medicines. SPAQ medicines procured by Malaria Consortium are from one of the 3 manufacturers with WHO prequalification, with whom Malaria Consortium has framework agreements: Tridem Pharma, S Kant Healthcare Ltd, or MacLeods Pharmaceuticals Ltd. Each monthly SMC cycle consists of one dispersible tablet of SP and three daily dispersible tablets of AQ. There are two doses of SPAQ: a lower dose for children aged three to \<12 months, and a higher dose for children aged 12 to 59 months. For children aged 12 to 59 months, the dosage comprises a single dose of a full tablet of SP 500/25mg and three daily doses of a full tablet of AQ 153mg. Those aged three to \<12 months are administered half the dose given to those aged 12 to 59 months, given as full dispersible tablets.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: March 26, 2024
• Primary Completion: May 26, 2024
• Study Completion: November 26, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03