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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: www.pactr.org

Trial no.: PACTR2010050002022487 Date registered: 2010/04/04
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 Malaria ,
Purpose of the trial Prevention
Anticipated trial start date 2010-04-19
Actual trial start date 2010-04-19
Anticipated date of last follow up 2011-04-18
Actual date of last follow up
Anticipated target sample size (number of participants) 1920   
Actual target sample size (number of participants) 1920   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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)

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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Months 80 Years 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 2009/07/28 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 2009/09/04 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
Dan bare Kumbotso LGA, Kano State Nigeria Kano +234 Nigeria
Panshekara Village of Kumbotso LGA, Kano State Nigeria. 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
Malaria Care Foundation Bompai, Kano Kano +234 0864942150 Nigeria
Gongoni Nigeria Ltd Bompai, Kano Kano +234 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 Foundation
Primary Sponsor Malaria Care Foundation Bompai, Kano Kano +234 Nigeria 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 Fax
Public Enquiries Dr Muhammad Hamza drhamza1020@ymail.com +2348035053139
Street address City Postal code Country Position / Affiliation
Dept Of Medicine AKTH, Kano Kano +234 Nigeria Senior Registrar, Infectious Disease Unit Dept of Medicine, AKTH Kano
Role Name Email Phone Fax
Principal Investigator Dr Habib Abdulrazaq G. abdulrazaq_habib@ yahoo.co.uk +2348056909039
Street address City Postal code Country Position / Affiliation
Department of medicine AKTH, Kano, Nigeria. Kano +234 Nigeria Associate Professor
Role Name Email Phone Fax
Scientific Enquiries Dr Iliasu Zubairu ziliyasu@yahoo.com +2348035868293
Street address City Postal code Country Position / Affiliation
Department of Community Medicine AKTH, Kano- Nigeria Kano +234 Nigeria Senior Lecturer