Community of Tambai: Indoors and outdoors spraying with IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester)

Malaria

The spraying will be performed monthly during the first 3 months, bimonthly during the next 6 months and then quarterly thereafter. The spraying will be carried out inside and outside the houses during the morning.

IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester) house spraying

Centro de Investigação Operacional da Beira, Instituto Nacional de Saúde, Ministério de Saúde, Mozambique

Evaluation of IR3535 as a Spatial Repellent for Malaria Control.

Evaluation of IR3535 as a Spatial Repellent for Malaria Control. (Avaliação da eficácia do Repelente Ambiental 3-(N-acetyl-n-butyl) Aminopropionic Acid Ethyl Ester (IR3535) Como Ferramenta Para o Controlo da malária).

Malaria cases in children aged 6 to 59 months

Mosquitoes resting inside the houses will be collected by aspiration

Outside mosquitoes collected overnight using CDC-light traps

Number of infected mosquitoes determined by PCR

An evaluation scale will be defined with the attribution of points for correct answers, and whoever has <50% will be considered a participant with a bad level of knowledge, attitudes and practices and whoever has 50% -74% and ≥75% will be considered medium and high level of knowledge, attitudes or practices respectively

The mosquito breeding sites will be mapped using the "participatory mapping" approach (Dickin et al. 2014). Community generated maps will be digitized on a GIS to create a georeferenced map of community knowledge.

Malaria cases in the locality of Bebedo will be monitored through patients of all ages with suspected malaria, attending the Vinho Health Center. Blood will be collected, for blood-smears and PCR.

The data collected from this study will be disseminated to different audiences at different times.
A final report will be presented to the Sofala Provincial Health Directorate, Nhamatanda District Health Directorate and the Ministry of Health trough the National Institute of Health.
In order to return the results to the communities, a meeting with the local structures of the communities will be held. The session will open to the general population using a language that will be accessible to the participants in this study, with emphasis on implementing and maintaining practices that protect them from malaria over time.
The results will also be disseminated to the scientific community through publications and presentations at national and international scientific conferences.
Data and specimens will be available for related studies to MSc and PhD theses at CIOB, Mozambique.

Henrique Silveira

Professor

Universidade Nova de Lisboa

Centro de Investigação Operacional da Beira, Mozambique

Fundação Belmiro de Azevedo, Portugal

A prospective experimental Before-After-Control-Intervention test will be carried out with two groups: a) Intervention (community of Tambai): with indoors and outdoors spraying with IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester) and b) Control (community of Micheu 1): without spraying.

Phase 1 (run-in): Marevan®
Phase 2: Marevan®
Phase 3: generic warfarin #1
Phase 4: generic warfarin #2

Phase 1 (run-in): generic warfarin #1
Phase 2: generic warfarin #1
Phase 3: Marevan®
Phase 4: generic warfarin #2

Phase 1 (run-in): generic warfarin #1
Phase 2: generic warfarin #1
Phase 3: generic warfarin #2
Phase 4: Marevan®

Phase 1 (run-in): Marevan®
Phase 2: Marevan®
Phase 3: generic warfarin #2
Phase 4: generic warfarin #1

Phase 1 (run-in): generic warfarin #2
Phase 2: generic warfarin #2
Phase 3: Marevan®
Phase 4: generic warfarin #1

Phase 1 (run-in): generic warfarin #2
Phase 2: generic warfarin #2
Phase 3: generic warfarin #1
Phase 4: Marevan®

Atrial Fibrillation

Branded warfarin sodium tablets (manufacturer União Química Farmacêutica Nacional S/A, Brazil) by mouth; dose adjusted according to INR and medical judgement.

Marevan®

Generic warfarin sodium tablets, manufacturer (União Química Farmacêutica Nacional S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

generic warfarin #1

Generic warfarin sodium tablets, manufacturer (Laboratório Teuto Brasileiro S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.

generic warfarin #2

Hospital São Paulo/Hospital Universitário da UNIFESP (University Hospital of UNIFESP)

Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

Therapeutic Equivalence Between Branded and Generic Warfarin Sodium Tablets in Adult Patients With Atrial Fibrillation in Brazil - Crossover Randomized Controlled Equivalence Trial

INR: International normalized ratio. INR will be assessed twice a month during the 16 weeks of study.
Delta INR will be calculated by the difference, in absolute numbers (i.e. in module), between the two valid INR measurements due for each patient with each formulation at each period. Difference between the delta INRs will be the outcome. We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

INR: International normalized ratio. INR will be assessed twice a month during the 16 weeks of study.
We will calculate the mean INR for each formulation of warfarin; difference between the mean INRs will be the outcome. We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

The warfarin dosage will be calculated as the sum of the dosage taken in the week before the study visit, as referred by the patient. We will calculate the mean dosage for each formulation of warfarin; difference between the mean dosage will be the outcome.
We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

Includes ischemic stroke (differential diagnosis with hemorrhagic stroke by tomography) and thromboembolism of viscera or extremities (diagnosed by acute symptoms and relevant diagnostic tests).

Classified as major or minor bleeding events.
Major: intracranial hemorrhage, fatal bleeding, bleeding resulting in hemoglobin loss equal to or greater than 2.0 g / L, hemorrhage requiring transfusion, bleeding in sensitive areas such as the retina or pericardium.
Minor: all other bleeding.

TTR calculated by Rosendaal Method also known as linear interpolation method. We will calculate the mean TTR for each formulation of warfarin; difference between the mean TTRs will be the outcome.
We will compare generic to branded warfarin (Marevan®) and the generic formulations to each other.

Carolina Gomes Freitas

Graduate student (PhD)

Federal University of São Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Aspirin (1 day after a single, 625 mg dose)

ethyl ester/hemorragia

Evaluation of IR3535 as a Spatial Repellent for Malaria Control.

Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

Effects of Omacor and Aspirin on Platelet Function

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