NCT06337253|UnknownPhase 4
Loading search results
Sponsor study identifier
interventional
1,000
0 countries
N/A
Study Start
March 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2024
Actual (reported)March 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 29, 2024
Actual (reported)May 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Uncomplicated malaria within 28 days
28 days
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Sulfadoxine/pyrimethamine plus amodiaquine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordSam Gudoi
Malaria Consortium
Maria Suau Sans
CONTACT
First Submitted
March 22, 2024
First Posted
March 29, 2024
Contact the study team to confirm eligibility.
Study Start
March 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 26, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 29, 2024
Record last verified: 2024-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: