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.: PACTR201611001721299 Date of Registration: 22/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ecologic MalarIa Reduction for Africa
Official scientific title Ecologic MalarIa Reduction for Africa
Brief summary describing the background and objectives of the trial The biological larvicides namely Bacillus thuringiensis israelensis (Bti) has an added ecological value, because its use remains harmless to humans and other animal species. The method has been scientifically proven effective and safe and considered cost effective in reducing of more than 95% of mosquitoes in this region. In Sub Saharan Africa, particularly in poor rural settings, there is a multitude of environmental mosquito breeding sites. More detailed research is needed to find a method that could significantly reduce the amount of larvicide with acceptable impact on malaria transmission. The goal of this study is to reduce the incidence of malaria, especially in the high-risk group of infants and children under 5 years by application of a new, highly efficient strategy in the fight against malaria, based on the elimination of mosquito larvae that transmit malaria. In this project we analyze the ecologic and health impacts as well as the cost effectiveness of larval source management under different larviciding scenarios in a health district in Burkina Faso.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) EMIRA
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 01/06/2013
Actual trial start date 01/03/2013
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date 08/06/2016
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 154632
Recruitment status Completed
Publication URL http://dx.doi.org/10.3402/gha.v7.25908
Secondary Ids Issuing authority/Trial register
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bacillus thuringiensis israelensis (Bti) larvicide treatment Every 10 days Daily The project is designed as a prospective intervention study with a duration of 3 years (2013¿2015). Its spatial scale includes three arms of interventions and control, comprising a total of 127 villagesin Nouna District, Burkina Faso. Baseline data were gathered in 2013 while the larviciding intervention runs in 2014 and 2015 accompanied by the continuous collection of impact evaluation data. 51600
Experimental Group Full Bacillus thuringiensis israelensis (Bti) larvicide treatment Every 10 days Daily Exhaustive treatment of all detected breeding sites in and around 42 villages and the semi-urban district capital Nouna during the rainy season (extended for prevailing breeding sites). Larvicide application is performed using detailed maps of the villages and knowledge of the terrain. 51600
Experimental Group 50% Bacillus thuringiensis israelensis (Bti) larvicide treatment Every 10 days Daily Guided treatment using remote-sensing-derived risk maps for 42 villages. The 50% of most productive breeding sites regarding their larval densities are treated selectively. Maps for steered treatment are based on a prediction model using high spatial resolution satellite imagery. This intervention was chosen under cost-effectiveness consideration. 51600
Experimental Group Full treatment of all detected breeding sites in and around 42 villages Every 10 days 4 months All villages within this group will receive a full Bti larvicide treatment of all breeding sites every second week. Larvicide application from 2014 on will be performed using detailed maps of the villages 65524
Experimental Group Guided treatment using remote sensing derived risk maps for 42 villages Every 10 days 4 months Breeding sites within the villages in this group will be treated selectively, regarding their vector productivity. Maps for selective treatment are based on a prediction model using high spatial resolution satellite imagery 41093
Experimental Group Full treatment of all detected breeding sites in and around 42 villages Every 10 days 4 months All villages within this group will receive a full Bti larvicide treatment of all breeding sites every second week. Larvicide application from 2014 on will be performed using detailed maps of the villages 65524
Experimental Group Guided treatment using remote sensing derived risk maps for 42 villages Every 10 days 4 months Breeding sites within the villages in this group will be treated selectively, regarding their vector productivity. Maps for selective treatment are based on a prediction model using high spatial resolution satellite imagery 41093
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
. Being a village located in the study area . Obtain community consent for the intervention . Withdrawn consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 100 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 05/02/2014 Comité d'Éthique pour la Recherche en Santé
Ethics Committee Address
Street address City Postal code Country
Rue 14/19 Ouagadougou 03 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Malaria parasitemia in children under 5 years Two rounds of testing for malaria parasites are performed every year - Testing for malaria parasite before the onset of the rainy season (begining of the malaria transmission) - Testing during the high transmission period
Secondary Outcome Adult mosquitoes captured using light traps - In each village, three sample points are chosen with one outdoor and one indoor light trap each. - Data collection is performed every 14 days from May to November and collected mosquitoes are determined to species level.
Primary Outcome Reduction in the density of mosquitoes Every 14 days during the study period
Secondary Outcome Parasitemia in under 5 years children Two timepoints yearly: - In june, before the onset of the raining season - In september at the end of the rainy season
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherche en Santé de Nouna Rue Namory Keita Nouna NA Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
Manfred Lautenschläger Stiftung Manfred Lautenschläger Zeppelinstr. 151 Heidelberg 69121 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Dr. Dr. Rainer Sauerborn Im Neuenheimer Feld 324 Heidelberg 69120 Germany University
COLLABORATORS
Name Street address City Postal code Country
Dr. Peter Dambach Im Neuenheimer Feld 326 Heidelberg 69120 Germany
Dr Issouf Traoré Rue Namory Keita Nouna NA Burkina Faso
Dr. Achim Kaiser Ludwigstrasse 99 Waldsee 67165 Germany
Dr. h.c. Manfred Lautenschläger Manfred Lautenschläger Zeppelinstr. 151 Heidelberg 69121 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rainer Sauerborn rainer.sauerborn@urz.uni-heidelberg.de +496221565038 Im Neuenheimer Feld 324
City Postal code Country Position/Affiliation
Heidelberg 69120 Germany Director/Institut of Public Health
Role Name Email Phone Street address
Public Enquiries Peter Dambach peter.dambach@web.de +49622156361566 Im Neuenheimer Feld 326
City Postal code Country Position/Affiliation
Hiedelberg 69120 Germany Institute of Public health, University of Hiedelberg
Role Name Email Phone Street address
Public Enquiries Issouf Traore t_issouf2000@yahoo.fr +22670707496 Reu Namory Keita, P O Box 02
City Postal code Country Position/Affiliation
Nouna Burkina Faso Centre de recherche en sante de Nouna, Burkina Faso
Role Name Email Phone Street address
Scientific Enquiries Ali SIE sieali@yahoo.fr +22620537043 Rue Namory Keita
City Postal code Country Position/Affiliation
Nouna NA Burkina Faso Director/Centre de Recherche en Santé de Nouna
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information