OCA013-10_Efficacy proposal_DRC_300513_ERBamendments.doc - Study proposal MSF-OCA Efficacy study DRC April 2013 STUDY PROPOSAL EFFICACY OF

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Study proposal: MSF-OCA Efficacy study DRC, April 2013 S TUDY PROPOSAL E FFICACY OF A MODIAQUINE -A RTESUNATE AND A RTEMETHER -L UMEFANTRINE FOR THE TREATMENT OF UNCOMPLICATED CHILDHOOD P LASMODIUM FALCIPARUM M ALARIA MSF CATCHMENT AREA B ARAKA , S OUTH K IVU , DRC 1
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Study proposal: MSF-OCA Efficacy study DRC, April 2013 Proposed start date: August 2013 Study site: Baraka, South Kivu, DRC Principal investigator: Marit de Wit, Malaria Advisor, MSF-OCA Phone: +31 (0)20 520 8067 Email: [email protected] Co-investigators: Karla Bil, Health Advisor, MSF-Holland Erwan Piriou, Laboratory Advisor, MSF-Holland Ruby Siddiqui, Epidemiologist, MSF-UK Medical coordinators, MSF-South Kivu Bahizi Bizoza Patrick, Coordinator Malaria Program, Ministry of Health, South Kivu, DRC Collaborators: Prof. Dr Tom van Gool, Academic Medical Center, Holland Dr. Ian Woolley, Infectious Disease specialist, MSF-UK Implementing agency: Médecins Sans Frontières-OCA Sponsor: Médecins Sans Frontières-OCA 2
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Study proposal: MSF-OCA Efficacy study DRC, April 2013 C ONTENTS List of abbreviations ....................................................................................................................................................... 6 1 Introduction ............................................................................................................................................................. 8 1.1 Humanitarian and Health situation in DRC ........................................................................................ 8 1.2 Medecins Sans Frontieres in DRC ........................................................................................................... 9 1.3 Malaria in DRC ............................................................................................................................................... 9 1.4 Control and treatment of malaria in DRC ............................................................................................ 9 1.5 Background .................................................................................................................................................. 10 1.5.1 Malaria in MSF-OCA projects in DRC ........................................................................................ 10 1.5.2 Malaria control interventions in MSF-OCA projects in DRC ............................................ 11 1.6 Rationale for the study ............................................................................................................................. 11 2 OBJECTIVES ........................................................................................................................................................... 11 2.1 Study hypothesis ........................................................................................................................................ 11 2.2 Primary objectives ..................................................................................................................................... 11 2.3 Secondary objectives ................................................................................................................................ 12 3 Materials and Methods ...................................................................................................................................... 12 3.1 Study design ................................................................................................................................................. 12 3.2 Study sites ..................................................................................................................................................... 12 3.3 Study population ........................................................................................................................................ 13 3.4 Definitions ..................................................................................................................................................... 13 3.4.1 Definition of parent/caretaker .................................................................................................... 13 3.5 Inclusion and exclusion criteria ........................................................................................................... 13 3.6 Sample size ................................................................................................................................................... 14 3.7 Schedule of assessments ......................................................................................................................... 15 3.8 Study end points ......................................................................................................................................... 15 3.8.1 Early treatment failure (ETF) ...................................................................................................... 15 3.8.2 Late clinical failure (LCF) .............................................................................................................. 16 3
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Study proposal: MSF-OCA Efficacy study DRC, April 2013 3.8.3 Late parasitological failure (LPF) ............................................................................................... 16 3.8.4 Adequate clinical and parasitological response (ACPR) ................................................... 16 3.8.5 Non analysable endpoints ............................................................................................................. 16 3.8.6 Safety endpoints ............................................................................................................................... 17 3.9 Study treatments ........................................................................................................................................ 17 3.9.1 Regimens tested ................................................................................................................................ 17 3.9.2 Concomitant treatment .................................................................................................................. 18 3.9.3 Rescue treatment .............................................................................................................................. 18 3.10 Study procedure ......................................................................................................................................... 19 3.10.1 Screening and enrolment (Day 0) .............................................................................................. 19 3.10.2 Follow-up (day 1 to Day42) .......................................................................................................... 20 3.10.3 Measurement techniques .............................................................................................................. 21 3.11 Laboratory techniques ............................................................................................................................. 21 3.11.1 Malaria slides ..................................................................................................................................... 21 3.11.2 Haemoglobin measurement ......................................................................................................... 21 3.11.3 PCR genotyping ................................................................................................................................. 21 3.11.4 Quality control of malaria diagnosis ......................................................................................... 22 3.11.5 Molecular markers for anti-malarial drug resistance ........................................................ 22 3.12 Data analysis ................................................................................................................................................ 22 3.12.1 Data management ............................................................................................................................ 22 3.12.2 Analysis plan ....................................................................................................................................... 22 3.12.3 Study report ........................................................................................................................................ 23 3.13 Ethical considerations .............................................................................................................................. 24 3.13.1 Authorisation and collaborations .............................................................................................. 24 3.13.2 Informed consent ............................................................................................................................. 24 3.13.3 Confidentiality ................................................................................................................................... 24 3.13.4 Health services .................................................................................................................................. 24 3.13.5 Inducement ......................................................................................................................................... 24 4
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Study proposal: MSF-OCA Efficacy study DRC, April 2013 3.13.6 Risks and benefits ............................................................................................................................ 25 4 Implementation of the study ........................................................................................................................... 26 4.1 Human resources ....................................................................................................................................... 26 4.2 Training of study teams and pilot surveys ....................................................................................... 26 4.3 Supervision ................................................................................................................................................... 26 4.4 Timeframe and timing .............................................................................................................................. 27 4.5 Logistics and supplies .............................................................................................................................. 28 5 Appendix ................................................................................................................................................................. 29 5.1 Danger signs and definition of severe malaria ............................................................................... 29 5.1.1 General danger signs ....................................................................................................................... 29 5.1.2 Severe manifestations of P. falciparum in children ............................................................. 29 5.2 Screening form ............................................................................................................................................ 30 5.3 Patient Information Sheet .......................................................................................................................
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