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.: PACTR201411000882128 Date of Approval: 08/09/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Maltrials
Official scientific title Combining indoor residual spraying and long-lasting insecticidal nets for malaria prevention: a cluster randomized controlled trial in Ethiopia
Brief summary describing the background and objectives of the trial This proposal aims to assess whether the combined use of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) increases protection against malaria. The proposal is to conduct a cluster randomised controlled trial in Ethiopia to measure malaria incidence and transmission, insecticide resistance, and to assess whether mosquito nets result in an age shift in malaria morbidity before and after trials. We plan to do the research in the Adami Tullu area in the Ethiopian Rift Valley. The intervention will consist of four "arms": (IRS+LLINs, LLINs alone, IRS alone and control (routine practice)).The village is the unit of randomisation. The cost-effectiveness study will be performed prospectively alongside the trial. Our proposal addresses an important public health problem by targeting malaria, a disease that contributes substantially to ill health and death in children, among pregnant women and adults in sub-Saharan Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Maltrials
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 15/09/2014
Actual trial start date
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 35000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1154-2
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised We used SPSS to generate four randomly selected group. The seed was randomly selected by a person not linked to the research project. The randomozation was done in Norway. The the allocation of participants to the intervention arms was done in Ethiopia. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Long-lasting insecticidal nets Two Years Bed Net 8182
Experimental Group Indoor Residual Spraying Two years IRS 7242
Experimental Group LLINs + IRS Two years LLIN + IRS 7717
Control Group No special intervention Two years None 8026 Active-Treatment of Control Group
Control Group No special intervention Two years None 8026 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This is a community randomized trial. We will ionclude all househoilds who concent to participate. Households who do not consent to take part in the study 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 01/07/2013 Regional Commitee for Medical and Health Research (Rek Vest)
Ethics Committee Address
Street address City Postal code Country
Haukeland Universitetssykehus, Bergen 5020 Norway
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 13/11/2013 National Ethics Review Commitee
Ethics Committee Address
Street address City Postal code Country
P O Box 2490 Addis Ababa 0000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of Plasmodium falciparum and Pl vivax infection. We will do weekly house visits, and incidence rates will be calculated on a weekly basis
Secondary Outcome Anaemia Hgb measured at start and end of study
Secondary Outcome Entomological inoculation rates Monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Ababa University: the study is done in the Zwai area Zwai area Zwai district 0000 Ethiopia
Batu Zwai Batu 0000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Council of Norway Drammensveien 288 Oslo 0283 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Bergen P O Box 7800 Bergen 5020 Norway University
COLLABORATORS
Name Street address City Postal code Country
Dr Wakgari Deressa Addis Ababa University Addis Ababa 0000 Ethiopia
Dr Eskindir Loha Hawassa University Hawassa Ethiopia
Dr Hans Overgaard Norwegian University of Life Sciences, Universitetstunet 3 Aas 1430 Norway
Prof Bernt Lindtjorn University of Bergen, P O Box 7800 Bergen 5020 Norway
Dr Meshesha Balkew Addis Ababa University Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wakgari Deressa deressaw@gmail.com +251 911483714 .
City Postal code Country Position/Affiliation
Addis Ababa . Ethiopia Ass Professor
Role Name Email Phone Street address
Public Enquiries Bernt Lindtjorn bernt.lindtjorn@cih.uib.no +4795056812 Nordre Toppe 83
City Postal code Country Position/Affiliation
Mjølkeraen 5136 Norway Professor
Role Name Email Phone Street address
Scientific Enquiries Eskindir Loha eskindir_loha@yahoo.com +251 913233294 .
City Postal code Country Position/Affiliation
Hawassa . Ethiopia Ass Professor
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information