Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2010050002022487 Date of Approval: 04/04/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Rambo Mosquito paper in the prevention of malaria in Kumbotso LGA, Kano State Nigeria.
Official scientific title Effectiveness of Insecticide Paper containing transfluthrin (Rambo®) in the prevention of malaria in Kumbotso LGA, Kano State Nigeria.
Brief summary describing the background and objectives of the trial In Nigeria, which has the largest population at risk in Africa, malaria is still a major public health problem, as there is stable transmission through out the country.A randomised trial will be carried out in two villages of Kumbotso local government area (LGA) of Kano State, Nigeria. Kumbotso is one of the 44 LGAs of Kano State which according to the 2006 National Population Census has a population of 295,979 consisting of 149,447 males and 146,532 females (FRN, 2006).
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 19/04/2010
Actual trial start date 19/04/2010
Anticipated date of last follow up 19/04/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 1920
Actual target sample size (number of participants) 1920
Recruitment status Recruiting
Publication URL
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 Randomised simple randomisation using a randomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rambo Mosquito paper (Transfluthrin) 1 paper daily 12 Months Mosquito repellant 900
Control Group Control Group None None None 1020 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All selected households in the experiment and control arms that consented for the study. Refusal to consent by head of the household. 6 Month(s) 80 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 28/07/2009 Aminu Kano Teaching Hospital, Kano
Ethics Committee Address
Street address City Postal code Country
Zaria Road, Kano Kano +234 Nigeria
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 04/09/2009 Ministry of Health, Kano State
Ethics Committee Address
Street address City Postal code Country
Post Office Road, Kano Nigeria Kano +234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Documented fever episodes at the PHC / CHC during the study period. 0 months 3 months 6 months 9 months 12 months
Primary Outcome ¿ Malarial parasitaemia 0 months 3 months 6 months 6 months 12 months
Primary Outcome ¿ Use of Coartem ® by families and at the health facilities 0 months 3 months 6 months 9 months 12 months
Primary Outcome ¿ Packed cell volume (Haematocrit) 0 months 3 months 6 months 9 months 12 months
Secondary Outcome Spleen Rates 0 months, 3 months, 6 months, 9 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Panshekara Village of Kumbotso LGA, Kano State Nigeria. Kumbotso LGA, Kano State Nigeria. Kano +234 Nigeria
Dan bare Kumbotso LGA, Kano State Nigeria Kano +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Gongoni Nigeria Ltd Bompai, Kano Kano +234 Nigeria
Gongoni Nigeria Ltd Bompai, Kano Kano +234 Nigeria
Malaria Care Foundation Bompai, Kano Kano +234 0864942150 Nigeria
Malaria Care Foundation Bompai, Kano Kano +234 0864942150 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Malaria Care Foundation Bompai, Kano Kano +234 Nigeria Charities/Societies/Foundation
Primary Sponsor Malaria Care Foundation Bompai, Kano Kano +234 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Gongoni Company Ltd Bompai Kano Kano +234 Nigeria
Gongoni Company Ltd Bompai Kano Kano +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Habib Abdulrazaq G. abdulrazaq_habib@yahoo.co.uk +2348056909039 Department of medicine AKTH, Kano, Nigeria.
City Postal code Country Position/Affiliation
Kano +234 Nigeria Associate Professor
Role Name Email Phone Street address
Public Enquiries Muhammad Hamza drhamza1020@ymail.com +2348035053139 Dept Of Medicine AKTH, Kano
City Postal code Country Position/Affiliation
Kano +234 Nigeria Senior Registrar, Infectious Disease Unit Dept of Medicine, AKTH Kano
Role Name Email Phone Street address
Scientific Enquiries Iliasu Zubairu ziliyasu@yahoo.com +2348035868293 Department of Community Medicine AKTH, Kano- Nigeria
City Postal code Country Position/Affiliation
Kano +234 Nigeria Senior Lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information