Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201305000551876 Date of Approval: 14/05/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title An integrated malaria control strategy including community case management and Seasonal Malaria Chemoprevention in Senegal.
Official scientific title Feasibility, safety and effectiveness of combining Home based Malaria Management and Seasonal Malaria Chemoprevention in children less than 10 years in Senegal: a cluster-randomised trial
Brief summary describing the background and objectives of the trial Although combined malaria control strategies are likely to reduce the malaria burden, there is limited information about the feasibility of combining several antimalarial interventions at community level. This study aims to assess the feasibility, effectiveness and safety of combining Home based Malaria Management (using RDT, ACTs, Rectal artesunate) and Seasonal Malaria Chemoprevention delivered by community health workers in Senegal (CHWs).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/09/2010
Actual trial start date 15/09/2010
Anticipated date of last follow up 14/09/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 1010
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
027/MSP/DS/CNRS Senegalese National Ethical Committe
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised The randomization unit will be the CHW in order to avoid contamination. The CHWs will be randomized using a random number generator from Excel software. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Home based malaria management (HMM) and Seasonal Malaria Chemoprevention (SMC) HMM: artemether-lumefantrine (AL); dosing according to age group - duration: 3 days. SMC: SP-Amodiaquine (day1:SP-AQ; days 2 and 3: Amodiaquine) 3 days HMM:For uncomplicated malaria cases, treatment will be done by CHWs using artemether-lumefantrine according to age group. SMC:In the four villages with combined HMM and SMC, all doses of AQ and SP will be administered by CHWs under direct observation. SMC drug delivery will be organized at the level of health huts 500
Control Group Home based malaria management (HMM) HMM: artemether-lumefantrine (AL); dosing according to age group - duration: 3 days 3 days Treatmen of uncomplicated malaria case by CHWs using artemether-lumefantrine 500 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children aged from 1 to 10 years living the area of Bonconto health post. - Parents or responsible inform consent. - Community consent. - Allergy to Amodiaquine or SP or AL drugs. - Presence of any severe or chronic illness. 1 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/03/2010 Conseil National de Recherche en Santé
Ethics Committee Address
Street address City Postal code Country
Ministère de la Santé du Sénégal, Rue Aimée Césaire Dakar-Fann Dakar 99999 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence rate of malaria attacks in the two groups of communities (HMM+SMC and HMM alone) over the transmission season throughout an active surveillance system. Children enrolled in the study will be assigned to a weekly follow up during the transmission season. They will be visited at home by CHW once a week during 12 weeks.
Secondary Outcome SMC coverage defined by the proportion of children who received the 3 doses of SMC during the transmission season Monthly, after SMC round
Secondary Outcome Safety and drug tolerability assessed by the incidence of adverse events during the study period. Passive surveillance system based on self reporting
Secondary Outcome Malaria diagnostic accuracy assessed by comparing RDT results performed by CHWs and slide microscopy. Any time a malaria RDT is performed, a slide microscopy will be done.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bonconto health post Rural area Velingara District Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Malaria Capacity Developement Consortium (MCDC) London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Cheikh Anta DIOP of Dakar Avenue Cheikh Anta DIOP Dakar PoBox: 5005 Fann Senegal University
COLLABORATORS
Name Street address City Postal code Country
Centre For Medical Parasitology (CMP) Bartholinsgade 2 Copenhagen 1356 Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roger TINE roger.tine@ucad.edu.sn +221 33 825 19 98 Avenue Cheikh Anta DIOP
City Postal code Country Position/Affiliation
Dakar PoBox: 5005 Dakar F Senegal Senior Lecturer - Department of Parasitology ¿ University Cheikh Anta DIOP of Dakar
Role Name Email Phone Street address
Public Enquiries Samba Cor SARR bathie65@yahoo.fr +221 77 647 09 99 Ministère de la Santé du Sénégal, Avenue Aimée Césaire
City Postal code Country Position/Affiliation
Dakar Senegal Head of the Senegalese National Ethical Committee
Role Name Email Phone Street address
Scientific Enquiries Oumar GAYE ogaye@refer.sn +221 33 825 19 98 Avenue Cheikh Anta DIOP
City Postal code Country Position/Affiliation
Dakar PoBox: 5005 Fann Senegal Professor of Parasitology Department of Parasitology ¿ University Cheikh Anta DIOP of Dakar
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks
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