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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204794105273 Date of Registration: 25/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and tolerability of combining deworming and anti-malaria drugs among pre-school and school-aged children in Senegal
Official scientific title Feasibility and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention (SMC) platform in a West African paediatric population
Brief summary describing the background and objectives of the trial Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and Schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MALHELMIN
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria,Soil-transmitted helminthiasis and Schistosomiasis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 26/06/2022
Actual trial start date
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://pubmed.ncbi.nlm.nih.gov/37957702/
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Amodiaquine plus sulphadoxinepyrimethamine plus albendazole and or praziquantel Amodiaquine = 153 mg Sulphadoxine-pyrimethamine= 500mg + 25mg Albendazole = 400mg Praziquantel = 40mg/kg= Once Albendazole and praziquantel will be administered (once) 24 hours to the children on day 0 of the study, followed by the administration of amodiaquine with sulphadoxine-pyrimethamine on day 1 and amodiaquine on days 2 and 3 of the study 300
Control Group Amodiaquine plus sulphadoxinepyrimethamine only Amodiaquine = 153 mg Sulphadoxine-pyrimethamine= 500mg + 25mg Amodiaquine plus Sulphadoxine-pyrimethamine on Day 1, and amodiaquine on days 2 and 3 of the study Children randomised to the control group receive only amodiaquine plus sulphadoxine-pyrimethamine on day 1, and amodiaquine on days 2 and 3 of the study. 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Male and female children aged 1-14 years; • Provision of a written informed consent by the parent/caregiver and a positive assent by children aged ≥ 12 years (in line with legal regulations in Senegal); • Willingness to provide finger-prick blood samples, urine, and stool samples; • Residence in the study area for at least six months. • Acutely ill child at the time of the drug administration; • Child whose parents/caregivers decline to provide consent; • A known HIV positive child receiving cotrimoxazole prophylaxis; • A child who has received a dose of either SP, AQ, ALB or PZQ during the previous six months; • A child with a known allergy to any of SP, AQ, ALB or PZQ. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 14 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 20/04/2022 London School of Hygiene Tropical Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • All solicited and unsolicited adverse events and adverse drug reactions will be assessed for causal relationships to the study medications. Consecutive six days after administration of the study drugs
Secondary Outcome • Prevalence and intensity of Plasmodium-helminth co-infection o Faecal egg counts for each of the four parasites (hookworm, A. lumbricoides, T. trichiura, and S. mansoni) and urine egg count for S.haematobium will be recorded, and the prevalence and arithmetic mean intensity of infection, including both positive and negative individuals will be calculated, before and after co-administration of SMC and anthelminthic drugs • Prevalence of anaemia and mean haemoglobin concentration o Haemoglobin concentration of all children will be checked using HemoCue®, before and after co-administration of SMC and anthelminthic drugs Before administration of study drugs and at the end of malaria transmission season
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Saraya district Kedougou region Saraya Saraya 00221 Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
UK Research and Innovation Polaris House, Polaris Way, North Star Avenue, Swindon, Wiltshire London SN2 1UH United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Professor Jean Louis Ndiaye University of Thies Thies 00221 Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhammed Afolabi Muhammed.Afolabi@lshtm.ac.uk +447535954947 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Clinical Associate Professor
Role Name Email Phone Street address
Public Enquiries Jean Louis Ndiaye jlndiaye@univ-thies.sn +221776445917 Thies
City Postal code Country Position/Affiliation
Thies 00221 Senegal Professor
Role Name Email Phone Street address
Scientific Enquiries Brian Greenwood Brian.Greenwood@lshtm.ac.uk +442072994707 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the summary results of this trial or a link to the summary results within the trial registration record within 12 months of the study completion date Informed Consent Form,Study Protocol Within 12 months of the study completion date Open access requests will be entertained, the decision will be made by the Principal Investigator, quality of the request will be reviewed before granting it
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