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.: PACTR201907479787308 Date of Approval: 15/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II)
Official scientific title Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II): a double-blind, cluster-randomized control trial for integrated control of malaria.
Brief summary describing the background and objectives of the trial The RIMDAMAL II trial is designed to determine the efficacy of adding seasonal ivermectin mass drug administrations to the standard-policy malaria control measures in the Sahel (seasonal malaria chemoprevention in children, maximum long-lasting insecticidal net coverage, intermittent preventive treatment in pregnancy), for reducing the incidence of uncomplicated malaria episodes in enrolled village children (≤ 10 years of age) assessed by active case surveillance. We will also examine the safety of the intervention, as well as entomological and parasitological endpoints. This is a double-blind, cluster randomized trial in that will occur in villages in southwestern Burkina Faso over two consecutive rainy seasons. For the intervention, mass administration of ivermectin or placebo will be given monthly over 4 months of each rainy season to the eligible villagepopulation, each as 3-day course of 300 μg/kg/day. These mass drug administrations will occur simultaneously with the distribution of seasonal malaria chemoprevention drugs on the same monthly schedule to eligible children aged 3-59 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RIMDAMALII
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 30/06/2019
Actual trial start date 30/06/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/07/2023
Anticipated target sample size (number of participants) 4700
Actual target sample size (number of participants) 4700
Recruitment status Active, not 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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ivermectin Ivermectin will given monthly from July-October (4 times) as a 3-day course of 300 μg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. Ivermectin (6 mg tablet) will be given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands. Generic Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 μg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. 2350
Control Group Placebo Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. Placebo given monthly from July-October (4 times) as a 3-day course Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. 2350 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Residence in selected study village Able to understand the information and willing to give consent or assent (age 12-18) and parent/guardian consent if study participant age is < 18 years of age. Residence outside of the study village Height < 90 cm (*note: if subject becomes ≥90cm over course the trial, this exclusion criteria will no longer be valid in subsequent MDA) Current treatment with SP+AQ as part of SMC (restricted to children 3-48 months old) (*note: if subject discontinuous SP+AQ treatment because they become older than 48 months over course the trial, this exclusion criteria will no longer be valid in subsequent MDA) Permanent disability or serious medical illness that prevents or impedes study participation and/or comprehension Pregnancy (screened for in women of child-bearing age [ages 15-45] using a pregnancy urine rapid test [e.g. SD Bioline hCG] the week prior to each MDA) Breast feeding if infant is within 1 week of birth Known allergy to ivermectin Possibility of Loa loa infection as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, Democratic Republic of Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria, and Sudan. Enrolled in any other active clinical trials 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 61 Month(s) 999 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 09/01/2019 COMITE DETHIQUE POUR LA RECHERCHE EN SANTE
Ethics Committee Address
Street address City Postal code Country
OUAGADOUGOU Ouagadougou 7009 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Malaria incidence Incidence of uncomplicated malaria episodes in enrolled village children ≤ 10 years of age Approximately 8 months over 2 consecutive rainy seasons
Secondary Outcome Harms Incidence of harms in the study population over the course of the intervention period 2 years from the start of the intervention in July of 2019
Secondary Outcome Entomological indices Blood fed mosquito mortality, entomological inoculation rate, and human exposure to anopheline mosquito bites over time will be compared between intervention and control arms Approximately 8 months over 2 consecutive rainy seasons
Secondary Outcome 3. Parasitological indices Plasmodium spp. prevalence, density, multiplicity of infection and molecular force of infection will be compared between intervention and control arms Approximately 8 months over 2 consecutive rainy seasons
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut de Recherche en Sciences de la Sante 399, Avenue de la Liberte Bobo Dioulasso Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health BG 560 1FL RM 8A39, 5601 Fishers Lane, Rockville 20852 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Colorado State University 1692 Campus Delivery, 80523 Fort Collins 805231692 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Teun Bousema Postbus 9101, Nijmegan Netherlands
Hannah Slater Norfolk Place, Street. London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Brian D. Foy brian.foy@colostate.edu +9704913470 1692 Campus Delivery, , CO, USA, 80523-1692
City Postal code Country Position/Affiliation
Fort Collins 80523 United States of America Professor
Role Name Email Phone Street address
Principal Investigator Sunil Parikh sunil.parikh@yale.edu +12037377906 60 College Street, P.O. Box 208322
City Postal code Country Position/Affiliation
New Haven 06520 United States of America Associate Professor
Role Name Email Phone Street address
Principal Investigator K. ROCH DABIRE dabireroch@gmail.com +22670739069 399, AVENUE DE LA LIBERTE
City Postal code Country Position/Affiliation
BOBO Burkina Faso RGIONAL DIRECTOR
Role Name Email Phone Street address
Public Enquiries Fabrice SOME afabricesome@yahoo.fr +22670011380 399, AVENUE DE LA LIBERTE
City Postal code Country Position/Affiliation
BOBO Burkina Faso STUDY COORDINATOR
Role Name Email Phone Street address
Scientific Enquiries SENI KOUANDA senikouanda@gmail.com +22670241462 Avenue du Capitaine Thomas Sankara
City Postal code Country Position/Affiliation
OUAGADOUGOU Burkina Faso CHAIR OF NATIONAL ETHICAL COMMITTEE
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected from this study, including de-identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. The study protocol, statistical analysis plan, and informed consent forms are available on ClinicalTrials.gov. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 6 mos of publication of the primary outcomes of the study. Human Subjects Protection Review Board Status: Approved Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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