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.: PACTR201310000575267 Date of Approval: 27/06/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A trial of targetted control to eliminate malaria in Central Senegal
Official scientific title Randomized trial of spatially targetted malaria control to virtually eliminate malaria in areas of very low incidence and patchy transmission in Senegal.
Brief summary describing the background and objectives of the trial In central Senegal where malaria incidence is low and good access to diagnosis and treatment is provided through health facilities and community case management, malaria can be virtually eliminated by a strategy of targetted IRS and MSAT (mass screening with RDT and treatment with ACT), with target areas defined from RDT-confirmed incident cases of clinical malaria detected by health workers. We propose a randomized control trial to assess this hypothesis.
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 Treatment: Drugs
Anticipated trial start date 16/06/2013
Actual trial start date
Anticipated date of last follow up 07/11/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 497379
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
LSHTM EC6387 London School of Hygiene and Tropical Medicine Ethics Committee
SEN13/20 Ethics committee of the Senegalese Ministry of Health
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 done externally Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mass Screening And Treatment Two rounds of MSAT will be organised in early September and November 2013 and 2014. Eurartesim tablets packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets of DHA- PQ, as film-coat 2 years households will be visited at the beginning of September and again at the end of October by community health workers (CHWs) who at each visit will take a finger prick blood sample to test for malaria using a rapid diagnostic test, and treat with dihyroartemisinin-piperaquine (DHA-PQ) if the test is positive. 105948
Experimental Group Insecticide residual spraying Once a year 4 weeks starting mid July 2013 and 2014 Actellic 300 CS, a new long-lasting capsule suspension (CS) formulation of the organophosphate insecticide, pirimiphos-methyl, will be used according to WHO guidelines. The P-methyl active ingredient can cause skin and eye irritation but encapsulating the active ingredient has improved the safety profile, actellic CS is in a low WHO hazard category - Class U ¿unlikely to present acute hazard in no 233902
Experimental Group MSAT Eurartesim tablets packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets of DHA- PQ, as film-coated tablets containing 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) a 2 years In May, targeted villages are identified based on the previous year¿s data. In June, all consenting households in the hotspot areas will receive IRS from district spray teams, and these same households will be visited at the beginning of September and again at the end of October by community health workers (CHWs) who at each visit will take a finger prick blood sample to test for malaria using a r 191594
Experimental Group IRS 1g/m2 2 years Actellic 300 CS, a new long-lasting capsule suspension (CS) formulation of the organophosphate insecticide, pirimiphos-methyl, will be used according to WHO guidelines. The P-methyl active ingredient can cause skin and eye irritation but encapsulating the active ingredient has improved the safety profile, actellic CS is in a low WHO hazard category - Class U ¿unlikely to present acute hazard in no 318538
Experimental Group IRS+MDA IRS July/Aug MDA Sept and Oct 2 years Targetted IRS (Actellic 300CS)+MDA(DHA-PQ) 15
Control Group Control 2 years National malaria contorl policies only 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
In each year of intervention, hotspot areas will be defined on the basis of the previous year¿s malaria cases. Within the hotspots in the intervention clusters, all households will be offered IRS spraying, and all persons over 3 months of age will be included in MDA and MSAT rounds. For the cross sectional survey each year, participants (all ages, both genders) will be selected randomly from the DSS database, all selected persons who consent to participate will be included. Pregnant women will be eligible for treatment with DHA-PQ if they are in the second or third trimester (more than 3 months since last menstrual period, or after quickening (first movements of the baby detected by the mother). Health posts in urban and semi-urban areas will be excluded. Households will be excluded from IRS if the head of the household does not consent. They will remain eligible for other aspects of the trial. In MDA and MSAT arms, households will not be included if the head of the household refuses. Individuals will be included only if they (or their mother/carer) consent. In the MDA arm of the trial, treatment with DHA-PQ will be withheld from babies under 3 months of age, from person with history of allergy to ACTs, from persons who are unwell and require medical attention, and from women who say they are pregnant. Persons who are unwell will be referred to the nearest health facility. In the MSAT arm, babies under 3 months of age will not be screened. Women in the first trimester of pregnancy (pregnant for less than 3 months) and women who believe they may be pregnant, who test positive for malaria by RDT, and persons with known allergy to ACTs who test positive by RDT, will not be treated with DHA-PQ, they will be given a referral card with their test result and referred for treatment at the nearest health post. Persons who are unwell with fever will be tested and treated with DHA-PQ if positive, or referred, in accordance with national guidelines for community case 3 Month(s) 99 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 07/05/2013 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevalence of malaria infection and incidence of malaria in year 2 Incidence during the second transmission season and prevalence in November of year 2
Secondary Outcome Prevalence of malaria infection in the hotspots This secondary outcome will be evaluated at the end of November 2014, therefore after 2 seasons of intervention
Secondary Outcome Incidence of malaria and prevalence of malaria infection in targetted and non-targetted areas in year 1 and year 2 Incidence in the transmission season and prevalence in November each year
Secondary Outcome Incidence of severe adverse events within 10 days of drug administration Within 10 days of each round of drug administration
Secondary Outcome Coverage of and adherence to the interventions Measured after each round of intervention and in a survey in November each year
Secondary Outcome The prevalence of molecular markers associated with resistance to PQ November each year (asymptomatics) and in positive RDTs from malaria cases during the transmission season
Secondary Outcome Costs of the interventions Over 2 years
Secondary Outcome Prevalence of infection by PCR and prevalence by serology November each year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
District sanitaire de Niakhar Bambey Bambey Bambey Senegal
District Sanitaire de Fatick Fatick Fatick Fatick Senegal
District sanitaire de Bambey Bambey Bambey Bambey Senegal
District sanitaire de Mbour Mbour Mbour Mbour Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
MRC/DFID/Wellcome Trust Global Public Health Trials Scheme London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Universite Cheikh Anta Diop, Dakar Senegal University
COLLABORATORS
Name Street address City Postal code Country
Paul Milligan LSHTM, Keppel Street London WC1E 7HT United Kingdom
El Hadj Ba IRD, UMR 198 URTMITE Dakar BP 1386 Senegal
Ousmane Faye PO Box 5005, UCAD Dakar Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Badara Cisse badara.cisse@lshtm.ac.uk +221-33 825 19 99 PO Box 5005 UCAD
City Postal code Country Position/Affiliation
Dakar Senegal Clinical Lecturer LSHTM
Role Name Email Phone Street address
Public Enquiries Paul Milligan paul.milligan@lshtm.ac.uk +44 (0)20 7636 8636 LSHTM, Keppel Street
City Postal code Country Position/Affiliation
London WC1E7HT United Kingdom Reader LSHTM
Role Name Email Phone Street address
Public Enquiries Oumar Gaye ogaye@refer.sn +221-33 825 19 99 PO Box 5005, University Cheikh Anta Diop
City Postal code Country Position/Affiliation
Dakar Fann Senegal Professor UCAD
Role Name Email Phone Street address
Scientific Enquiries Paul Milligan paul.milligan@lshtm.ac.uk +44 (0)20 7636 8636 LSHTM, Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Reader LSHTM
REPORTING
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Result URL Hyperlinks
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