DOCSLIB.ORG

FDA Briefing Document Tafenoquine Tablet, 100 Mg Meeting of The

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
FDA Briefing Document Tafenoquine Tablet, 100 Mg Meeting of The FDA Briefing Document Tafenoquine Tablet, 100 mg Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC) July 26, 2018 The committee will discuss new drug application (NDA) 210607 for tafenoquine tablet, 100 mg, sponsored by 60 Degrees Pharmaceuticals, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing. The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. The FDA have brought tafenoquine tablets to this Advisory Committee to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the Advisory Committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting. 1 Table of Contents 1 Introduction ........................................................................................................................................... 4 2 Background ............................................................................................................................................ 4 3 Product Information ............................................................................................................................... 4 4 Regulatory History ................................................................................................................................. 4 5 Clinical Pharmacology ........................................................................................................................... 4 6 Microbiology ......................................................................................................................................... 6 7 Pharmacology/Toxicology (Nonclinical Neurobehavioral Assessment) ............................................... 7 8 Overview of Clinical Development Program for the Prevention of Malaria ......................................... 8 8.1 Study 033 ...................................................................................................................................... 9 8.1.1 Study Design............................................................................................................................. 9 8.1.2 Statistical Methodologies.........................................................................................................10 8.1.3 Patient Disposition ...................................................................................................................11 8.1.4 Efficacy Results .......................................................................................................................12 8.2 Study 043 .....................................................................................................................................15 8.2.1 Study Design............................................................................................................................15 8.2.2 Statistical Methodologies.........................................................................................................16 8.2.3 Patient Disposition ...................................................................................................................17 8.2.4 Efficacy Results .......................................................................................................................18 8.3 Study 045 .....................................................................................................................................19 8.3.1 Study Design............................................................................................................................19 8.3.2 Statistical Methodologies.........................................................................................................20 8.3.3 Patient Disposition ...................................................................................................................21 8.3.4 Efficacy Results .......................................................................................................................22 8.4 Study 030 .....................................................................................................................................25 8.4.1 Study Design............................................................................................................................25 8.4.2 Statistical Methodologies.........................................................................................................26 8.4.3 Patient Disposition ...................................................................................................................26 8.4.4 Efficacy Results .......................................................................................................................27 8.5 Study TQ-2016-02 .......................................................................................................................28 8.5.1 Study Design............................................................................................................................28 8.5.2 Statistical Methodologies.........................................................................................................29 8.5.3 Patient Disposition ...................................................................................................................30 9 Overall Efficacy Summary ...................................................................................................................32 9.1 Assessment of Efficacy Across Trials ..........................................................................................32 2 9.2 Summary and Conclusions of Efficacy ........................................................................................33 10 Evaluation of Safety .............................................................................................................................34 10.1 Safety Summary ...........................................................................................................................34 10.2 Methods .......................................................................................................................................35 10.3 Adverse Event Analysis ...............................................................................................................36 10.4 Adverse Reactions of Special Interest and Submission Specific Safety Issues ............................38 10.4.1 Ophthalmic ..........................................................................................................................38 10.4.2 Cardiac ................................................................................................................................39 10.4.3 Hematologic ........................................................................................................................40 10.4.4 Renal ...................................................................................................................................41 10.4.5 Neurologic ...........................................................................................................................42 10.4.6 Psychiatric ...........................................................................................................................44 10.4.7 Hepatobiliary .......................................................................................................................46 10.4.8 Gastrointestinal ...................................................................................................................46 11 Draft Points for Advisory Committee Discussion ................................................................................46 3 1 Introduction This briefing document describing the safety and efficacy data for tafenoquine (TQ) was prepared by the FDA for panel members of the Antimicrobial Drugs Advisory Committee. The FDA would like the committee to discuss whether the data are adequate to support the safety and efficacy of TQ for the prevention of malaria in adults for up to 6 months of continuous dosing. 2 Background TQ is an 8-aminoquinoline antimalarial. TQ possesses activity against all pre- erythrocytic and erythrocytic stages of the Plasmodium species, including P. falciparum and P. vivax. The proposed indication is the prevention of malaria in adults for up to 6 months of continuous dosing. The indication encompasses all species of Plasmodia and includes prophylaxis while in the endemic region and post-exposure. The proposed regimen for TQ includes a loading dose of 200 mg (two 100 mg tablets) once daily for 3 days before travel to a malarious area, followed by 200 mg maintenance weekly dose while in the malarious area, followed by a single 200 mg dose in the week following exit from the malarious area. 3 Product
Load more

Recommended publications
  • Exposure to Holoendemic Malaria Results in Suppression of Epstein-Barr Virus-Specific T Cell Immunosurveillance in Kenyan Children
    University of Massachusetts Medical School eScholarship@UMMS Population and Quantitative Health Sciences Publications Population and Quantitative Health Sciences 2007-02-15 Exposure to holoendemic malaria results in suppression of Epstein-Barr virus-specific T cell immunosurveillance in Kenyan children Ann M. Moormann University of Massachusetts Medical School Et al. Let us know how access to this document benefits ou.y Follow this and additional works at: https://escholarship.umassmed.edu/qhs_pp Part of the Biostatistics Commons, Epidemiology Commons, Health Services Research Commons, Immunology and Infectious Disease Commons, and the Pediatrics Commons Repository Citation Moormann AM, Chelimo K, Sumba PO, Tisch DJ, Rochford RA, Kazura JW. (2007). Exposure to holoendemic malaria results in suppression of Epstein-Barr virus-specific T cell immunosurveillance in Kenyan children. Population and Quantitative Health Sciences Publications. https://doi.org/10.1086/ 511984. Retrieved from https://escholarship.umassmed.edu/qhs_pp/397 This material is brought to you by eScholarship@UMMS. It has been accepted for inclusion in Population and Quantitative Health Sciences Publications by an authorized administrator of eScholarship@UMMS. For more information, please contact [email protected]. MAJOR ARTICLE Exposure to Holoendemic Malaria Results in Suppression of Epstein-Barr Virus–Specific T Cell Immunosurveillance in Kenyan Children Ann M. Moormann,1 Kiprotich Chelimo,4 Peter O. Sumba,4 Daniel J. Tisch,2 Rosemary Rochford,3 and James W. Kazura1 1Center for Global Health and Diseases and 2Department of Epidemiology and Biostatistics, Case Western Reserve University, Cleveland, Ohio; 3Department of Microbiology and Immunology, State University of New York Upstate Medical University, Syracuse; 4Kenya Medical Research Institute, Center for Vector Biology and Control Research, Kisumu, Kenya Background.
    [Show full text]
  • Editorial Acquired Immunity in a Holoendemic Setting of Plasmodium Falciparum and P
    University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Public Health Resources Public Health Resources 2007 EDITORIAL ACQUIRED IMMUNITY IN A HOLOENDEMIC SETTING OF PLASMODIUM FALCIPARUM AND P. VIVAX MALARIA J. Kevin Baird ALERTAsia Foundation, [email protected] Robert W. Snow University of Oxford-Wellcome Trust Collaborative Programme, Nairobi, Kenya Follow this and additional works at: http://digitalcommons.unl.edu/publichealthresources Baird, J. Kevin and Snow, Robert W., "EDITORIAL ACQUIRED IMMUNITY IN A HOLOENDEMIC SETTING OF PLASMODIUM FALCIPARUM AND P. VIVAX MALARIA" (2007). Public Health Resources. 359. http://digitalcommons.unl.edu/publichealthresources/359 This Article is brought to you for free and open access by the Public Health Resources at DigitalCommons@University of Nebraska - Lincoln. It has been accepted for inclusion in Public Health Resources by an authorized administrator of DigitalCommons@University of Nebraska - Lincoln. Europe PMC Funders Group Author Manuscript Am J Trop Med Hyg. Author manuscript; available in PMC 2013 March 22. Published in final edited form as: Am J Trop Med Hyg. 2007 June ; 76(6): 995–996. Europe PMC Funders Author Manuscripts EDITORIAL ACQUIRED IMMUNITY IN A HOLOENDEMIC SETTING OF PLASMODIUM FALCIPARUM AND P. VIVAX MALARIA J. KEVIN BAIRD* and ROBERT W. SNOW ALERTAsia Foundation, Jakarta, Indonesia; Kenya Medical Research institute University of Oxford-Wellcome Trust Collaborative Programme, Nairobi, Kenya Most of what we presume to understand of naturally acquired immunity to Plasmodium falciparum malaria comes from studies in sub-Saharan Africa. The virtual absence of P. vivax malaria from most of that region leaves three important questions not addressed: 1) What is naturally acquired immunity to P.
    [Show full text]
  • Outbreak Epidemiology & Investigation
    Lecture 6 Outbreak Investigation February 2, 2017 ID Epidemiology (BMTRY 713) MUSC Dept. of Public Health Sciences Infectious Disease Epidemiology BMTRY 713 (A. Selassie, DrPH) February 2, 2017 Lecture 6 Outbreak Epidemiology & Investigation Learning Objectives 1. Define Outbreak, Epidemic, Endemic, & Pandemic 2. Describe the purpose of Outbreak investigation 3. List the main steps in outbreak investigation 4. Illustrate epidemic curves 5. Recognizer main types of outbreaks Outbreak epidemiology Study of a disease cluster or epidemic in order to control or prevent further spread of disease in a population It is a specific form of descriptive epidemiology intended to identify immediate threat to public health Requires urgent action Terminology Outbreak—a small localized cluster of cases, usually an infectious disease Epidemic—the occurrence of cases of a condition in a population in a number greater than expected for a given period of time Endemic—a constant presence of a communicable disease in a population – Holoendemic: high proportion of children affected, conferring immunity in adults. (e.g. malaria) – Hyperendemic: constant presence in all ages Pandemic—an epidemic that transcends national boundary extending to much of the world Selassie AW (DPHS) 1 Lecture 6 Outbreak Investigation February 2, 2017 ID Epidemiology (BMTRY 713) MUSC Dept. of Public Health Sciences Types of epidemics Common source – Single source of contamination – Single vehicle • Consider distribution patterns Point epidemics – Common source, everyone exposed at the same time Propagated epidemics – Transfer from one host to another – Bimodal with secondary cases – Overlapping secondary cases Mixed – Include both Point source epidemics (short) Point source epidemics (Long) Selassie AW (DPHS) 2 Lecture 6 Outbreak Investigation February 2, 2017 ID Epidemiology (BMTRY 713) MUSC Dept.
    [Show full text]
  • Dictionary of Epidemiology, 5Th Edition
    A Dictionary of Epidemiology This page intentionally left blank A Dictionary ofof Epidemiology Fifth Edition Edited for the International Epidemiological Association by Miquel Porta Professor of Preventive Medicine & Public Health School of Medicine, Universitat Autònoma de Barcelona Senior Scientist, Institut Municipal d’Investigació Mèdica Barcelona, Spain Adjunct Professor of Epidemiology, School of Public Health University of North Carolina at Chapel Hill Associate Editors Sander Greenland John M. Last 1 2008 1 Oxford University Press, Inc., publishes works that further Oxford University’s objective excellence in research, scholarship, and education Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi Shanghai Taipei Toronto With offi ces in Argentina Austria Brazil Chile Czech Republic France Greece Guatemala Hungary Italy Japan Poland Portugal Singapore South Korea Switzerland Thailand Turkey Ukraine Vietnam Copyright © 1983, 1988, 1995, 2001, 2008 International Epidemiological Association, Inc. Published by Oxford University Press, Inc. 198 Madison Avenue, New York, New York 10016 www.oup-usa.org All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of Oxford University Press. This edition was prepared with support from Esteve Foundation (Barcelona, Catalonia, Spain) (http://www.esteve.org) Library of Congress Cataloging-in-Publication Data A dictionary of epidemiology / edited for the International Epidemiological Association by Miquel Porta; associate editors, John M. Last . [et al.].—5th ed. p. cm. Includes bibliographical references and index. ISBN 978–0-19–531449–6 ISBN 978–0-19–531450–2 (pbk.) 1.
    [Show full text]
  • Reemergence of Epidemic Malaria in the Highlands of Western Kenya
    Dispatches Reemergence of Epidemic Malaria in the Highlands of Western Kenya M. A. Malakooti*, K. Biomndo, and G. D. Shanks *University of the Health Sciences, Bethesda, Maryland, USA; Brooke Bond Central Hospital, Kericho, Kenya; US Army Medical Research Unit, Nairobi, Kenya Hospital records (1990-1997) of a tea company in the Kericho district, western Kenya, showed malaria epidemics almost annually from May to July, with an annual attack rate of 50%, 857 hospitalizations per 100,000 per year, and 42 deaths per 100,000 per year; 32% of deaths in hospitalized patients were caused by malaria. A questionnaire survey (June 1997) of 244 patients hospitalized for malaria showed that only 8% had traveled to an area with known malaria transmission 30 days before diagnosis. The increasing malaria incidence may be due to drug resistance. This study investigated reports of epidemic transmission and epidemics at higher elevations. malaria in a highland area of Kenya traditionally Unlike the parasite, the mosquito vector can thought to be free of malaria to 1) formulate commonly be found at altitudes from >1,600 m recommendations for reducing disease incidence (3,4) to 3,000 m, demonstrating that the limiting and preventing future epidemics and 2) determine factor for malaria transmission at high altitude whether malaria was imported or was due to local is the survival of the Plasmodium parasite. The transmission. Anopheles population is very sensitive to rainfall, The factors necessary for malaria transmis- which increases the availability of mosquito sion are the Plasmodium parasite, the Anopheles breeding sites. A. gambiae, the primary malaria mosquito vector, and the human host.
    [Show full text]
  • 1 Are We Prepared for Emerging and Re-Emerging Diseases?
    Tanzania Journal of Health Research DOI: http://dx.doi.org/10.4314/thrb.v13i5.8 Volume 13 (Suppl 1), December 2011 Are we prepared for emerging and re-emerging diseases? Experience and lessons from epidemics that occurred in Tanzania during the last five decades ESRON D. KARIMURIBO1*, LEONARD E.G. MBOERA2, ERASTO MBUGI3, AZMA SIMBA4, FREDRICK M. KIVARIA5, PETER MMBUJI4 and MARK M. RWEYEMAMU1 1Southern African Centre for Infectious Disease Surveillance, Sokoine University of Agriculture, Morogoro, Tanzania 2National Institute for Medical Research, Dar es Salaam, Tanzania 3Muhimbili University of Allied and Health Sciences, Dar es Salaam, Tanzania 4Ministry of Health and Social Welfare, Dar es Salaam, Tanzania 5Ministry of Livestock and Fisheries Development, Dar es Salaam, Tanzania _________________________________________________________________________________ Abstract: This paper reviews preparedness for containing and controlling emerging and re-emerging diseases drawing lessons from disease events that occurred in animal and human populations in the last five decades (1961-2011). A comprehensive analysis based on retrieval and analysis of grey and published literature as well as reported cases was carried out to document type and trend of occurrence of emerging and re-emerging infectious diseases in different parts of Tanzania. Overall, the majority of diseases reported in the country were viral in nature followed by bacterial diseases. The trend for the occurrence shows a number of new emerging diseases as well as re-occurrence of old diseases in both animal (domestic and wild) and human populations. In humans, the major disease epidemics reported in the last five decades include cholera, influenza A H1N1, plague and rubella. In animals, the major epidemic diseases reported were Contagious Bovine Pleuropneumonia, Contagious Caprine Pleuropneumonia, Peste des petits ruminants and Giraffe Ear and Skin Diseases.
    [Show full text]
  • Intermittent Preventive Treatment of Malaria in Pregnancy: at the Crossroads of Public Health Policy
    Tropical Medicine and International Health doi:10.1111/j.1365-3156.2011.02765.x volume 00 no 00 Systematic Review Intermittent preventive treatment of malaria in pregnancy: at the crossroads of public health policy R. Matthew Chico and Daniel Chandramohan Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK Summary The intermittent preventive treatment of malaria in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) has been a key component of the focused antenatal care package for nearly a decade, reducing the burden of low birthweight attributable to malaria in sub-Saharan Africa. However, SP has lost parasite sensitivity in many sub-Saharan locations during the same period, rendering its beneficial effect in IPTp debatable. Malaria transmission has also declined in some epidemiological settings. There is no evidence to suggest, however, that the risk of malaria in pregnancy without preventive measures has declined in the same locations. Thus, the urgency to identify efficacious drugs and ⁄ or new strategies to prevent malaria in pregnancy remains as great as ever. We summarise the results of recently published SP-IPTp studies from areas of high drug resistance and ⁄ or low malaria transmission. We also present the evidence for mefloquine and azithromycin-based combinations (ABCs), two leading drug options to replace SP in IPTp. We discuss optimal dosing for ABCs and their likely protection against several sexually transmitted and reproductive tract infections. We also summarise data from a diagnosis-based alternative to IPTp known as the intermittent screening and treatment (IST) for malaria. Clinical and operational research is urgently needed to compare birth outcomes achieved by IPTp with ABCs vs.
    [Show full text]
  • Estimation of the Infectious Reservoir of Plasmodium Falciparum in Natural Vector Populations Based on Oocyst Size
    TRANSACTIONSOF THE ROYALSOCIETY OF TROPICAL MEDICINE AND HYGIENE (1996) 90,494-497 Estimation of the infectious reservoir of Plasmodium falciparum in natural vector populations based on oocyst size H. Hajilp 2, T. Smith3, J. Th. Meuwissen 4, R. Sauerwein4 and J. D. Charlwood’ ‘Ifakara Centre, P.O. Box 53, Ifakara, Tanzania; 2Ministy of Health, P.O. Box 236, Zanzibar, Tanzania; 3Swiss Tropical Institute, P.O. Box, CH-4002 Basel, Switzerland; 4Department of Medical Microbiology, University of Nijmegen, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands Abstract A method for determining the infectious reservoir of malaria (K) and vector survival rate (P) by measuring oocyst size and discriminating between the most recent and other infections is described. In the laboratory the mean diameter of 3 d oocysts in Anopheles gambiae, kept at 26°C was 115 pm and the mean diameter at day 5 was 245 Km. Oocyst sizes in wild caught mosquitoes from southern Tanzania, that had fed on the oc- cupants of bed nets with holes in the sides, were more variable. 2060 A. gambiae s.1. and 1982A. funestus were examined for oocysts 3 d after feeding; 796 and 654 oocysts from the 153 and 170 infected females, re- spectively, were measured. Becauseof misclassification errors, the use of a simple cut-off model, in which all oocysts less than 17.5 pm in diameter were considered to have arisen from the most recent feed, was thought to overestimate K and underestimate P. A statistical model which allows for overlap in the oocyst size distributions is described. Estimates of the infectious reservoir derived from this model were 2.8% for A.
    [Show full text]
  • Coronavirus Disease 2019 and Dengue—Double Trouble in the Tropics
    Hilmy et al. J Med Case Reports (2021) 15:171 https://doi.org/10.1186/s13256-021-02707-7 CASE REPORT Open Access Coronavirus disease 2019 and dengue: two case reports Abdullah Isneen Hilmy1*, Rajib Kumar Dey1, Hisham Ahmed Imad2,3, Abdul Azeez Yoosuf1, Ali Nazeem1 and Ali Abdulla Latheef1,4 Abstract Background: The pandemic of this century has overwhelmed the healthcare systems of afected countries, and all resources have been diverted to coronavirus disease 2019. At the onset, coronavirus disease 2019 can present as any other acute febrile undiferentiated illness. In tropical regions, clinicians are increasingly challenged to diferenti- ate these febrile illnesses without the use of diagnostics. With this pandemic, many of these tropical diseases are neglected and go underreported. Dengue is holoendemic in the Maldives, and dengue viruses circulate throughout the year. Reports about coinfections with dengue virus and severe acute respiratory syndrome coronavirus 2 are scarce, and the outcome and the dynamics of the disease may be altered in the presence of coinfection. We have described the clinical manifestation and serial laboratory profle, and highlighted the atypical fndings uncommon in dengue infection. Case presentation: Case 1 was a 39-year old Asian male, presented on day 6 of dengue infection with warning signs. Reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 that was done as per hospital protocol was found to be positive. Case 2 was a 38-year old Asian male, was admitted on day 5 of illness with symptoms of acute respiratory infection with positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2.
    [Show full text]
  • Characterization of the Infectious Reservoir of Malaria with an Agent
    Gerardin et al. Malaria Journal (2015) 14:231 DOI 10.1186/s12936-015-0751-y RESEARCH Open Access Characterization of the infectious reservoir of malaria with an agent-based model calibrated to age-stratified parasite densities and infectiousness Jaline Gerardin1*, André Lin Ouédraogo1,2, Kevin A McCarthy1, Philip A Eckhoff1 and Edward A Wenger1 Abstract Background: Elimination of malaria can only be achieved through removal of all vectors or complete depletion of the infectious reservoir in humans. Mechanistic models can be built to synthesize diverse observations from the field collected under a variety of conditions and subsequently used to query the infectious reservoir in great detail. Methods: The EMOD model of malaria transmission was calibrated to prevalence, incidence, asexual parasite density, gametocyte density, infection duration, and infectiousness data from nine study sites. The infectious reservoir was characterized by age and parasite detectability with diagnostics of varying sensitivity over a range of transmission intensities with and without case management and vector control. Mass screen-and-treat drug campaigns were tested for likelihood of achieving elimination. Results: The composition of the infectious reservoir is similar over a range of transmission intensities, and higher intensity settings are biased towards infections in children. Recent ramp-ups in case management and use of insecticide-treated bed nets (ITNs) reduce the infectious reservoir and shift the composition towards sub-microscopic infections. Mass campaigns with anti-malarial drugs are highly effective at interrupting transmission if deployed shortly after ITN campaigns. Conclusions: Low-density infections comprise a substantial portion of the infectious reservoir. Proper timing of vector control, seasonal variation in transmission intensity and mass drug campaigns allows lingering population immunity to help drive a region towards elimination.
    [Show full text]
  • Epidemiology of Malaria in a Holoendemic Area of Rural
    Ruprecht-Karls-University Heidelberg Institute of Hygiene Department of Tropical Hygiene and Public Health EPIDEMIOLOGY OF MALARIA IN A HOLOENDEMIC AREA OF RURAL BURKINA FASO Inaugural dissertation to obtain the degree of Dr. med. at the Medical Faculty of the Ruprecht-Karls-University Heidelberg Submitted by: Corneille TRAORE from Bomborokuy / Burkina Faso May 2003 Dekan: Prof. Dr. med. Dr. h.c. H.-G. Sonntag Referent: Prof. Dr. rer. nat. H. Becher Table of Contents List of abbreviations v 1 INTRODUCTION 1.1 History of malaria control 1 1.2 Global burden of malaria 3 1.3 Epidemiology of malaria 3 1.3.1 General considerations 3 1.3.2 Biological determinants 4 1.3.3 Malaria transmission 7 1.3.4 Malaria morbidity 10 1.3.5 Malaria mortality 16 1.3.6 Socio-demographic factors 19 1.3.7 Climatic and geographical parameters and malaria 20 1.3.8 Socio-economic parameters 21 1.3.9 Community knowledge about malaria 24 1.4 Statement of the problem in Burkina Faso 25 1.5 Aims of the study 26 2 STUDY DESIGN AND METHODS 2.1 Study area 27 2.2 Study design 31 2.2.1 Entomological study 32 2.2.2 Zinc supplementation study 33 2.2.3 ITN study 34 2.2.4 Community factors and malaria study 35 2.2.5 Chloroquine efficacy study 36 2.2.6 Mortality study 37 2.3 Malaria morbidity data 38 2.4 Data management and analysis 38 2.5 Ethical consideration 39 3 RESULTS 3.1 Malaria transmission 40 3.1.1 Vector species and transmission intensity 40 3.1.2 Parasites species 41 3.2 Malaria morbidity 42 3.2.1 Study children 42 3.2.2 Malaria incidence 42 3.2.3 Malariometric parameters
    [Show full text]
  • WHO Malaria Terminology This Document Was Updated in December 2019
    Global Malaria Programme WHO malaria terminology This document was updated in December 2019. Please consult the website for any content updates (http://www.who.int/malaria) Global Malaria Programme WHO malaria terminology © World Health Organization 2016. Updated in December 2019. All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication.
    [Show full text]