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.: PACTR202312489417172 Date of Approval: 07/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the effectiveness and cost-effectiveness of integrating mass drug administration for helminth control with seasonal malaria chemoprevention in Ghanaian children
Official scientific title Evaluating the effectiveness and cost-effectiveness of integrating mass drug administration for helminth control with seasonal malaria chemoprevention in Ghanaian children
Brief summary describing the background and objectives of the trial Malaria remains a major health problem, especially among children living in sub-Saharan Africa where more than 90% of the disease and deaths occur. Adding to this high burden among the children is the co-existence of parasitic worms in their intestines and urinary tract. The combined infection of malaria and parasitic worms in these children has additive adverse effects of anaemia, poor physical and cognitive development, and death. Limited empirical evidence exists on new approaches that maximise the impact of the control programmes for malaria and helminths among children in endemic countries. We conducted a randomised controlled trial in the first stage of this project to establish the feasibility and safety of integrating helminth control with seasonal malaria chemoprevention (SMC) among Senegalese children. This second stage will assess the effectiveness and cost-effectiveness of using the SMC platform to deliver deworming drugs to preschool and school-aged children living in communities where the burden of malaria and parasitic worms is high in central Ghana. One thousand, two hundred children aged 1-14 years will be randomly assigned equally to two study communities where antimalarial (SMC) drugs and deworming drugs will be administered in combination to the children living in one study community, and antimalarial (SMC) drugs alone will be delivered to the children living in the second study community. The effectiveness of the combined delivery will be determined by checking whether the combined antimalarial and deworming drugs prevent anaemia in the children who receive the combined drugs compared to the children who receive antimalarial drugs only. We will also determine the cost and cost-effectiveness of this approach by estimating the incremental cost savings due to cases of moderate and severe anaemia averted by giving antimalarial and deworming drugs together to the children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MALHELMIN 3 study
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria,Neglected Tropical Diseases - Soil Transmitted Helminths and schistosomiasis
Purpose of the trial Prevention
Anticipated trial start date 01/05/2024
Actual trial start date
Anticipated date of last follow up 02/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Not yet 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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group SMC group Sulphadoxine-Pyrimethamine (SP) tablet (500mg + 25mg) Children aged 12–59 months will receive a full tablet as a single dose on the first day. Children aged 5-14 years will receive two tablets as a single dose on the first day. Amodiaquine (AQ) tablet (153mg base) Children aged 12–59 months will receive a full tablet as a single daily dose for 3 consecutive days. Children aged 5-14 years will receive two tablets as a single dose for 3 consecutive days. The following drugs will be administered on a monthly basis for four months as specified below: Sulphadoxine-Pyrimethamine (SP) tablet (500mg + 25mg) Children aged 12–59 months will receive a full tablet as a single dose on the first day. Children aged 5-14 years will receive two tablets as a single dose on the first day. Amodiaquine (AQ) tablet (153mg base) Children aged 12–59 months will receive a full tablet as a single daily dose for 3 consecutive days. Children aged 5-14 years will receive two tablets as a single dose for 3 consecutive days. The interventions are standard drugs approved by the World Health Organisation for the preventive treatment of malaria (amodiaquine and sulphadoxine-pyrimethamine) 600 Active-Treatment of Control Group
Experimental Group SMC plus anthelminthic group Sulphadoxine-pyrimethamine (SP tablet) (500mg + 25mg) Children aged 12–59 months will receive a full tablet as a single dose on the first day. Children aged 5-14 years will receive two tablets as a single dose on the first day. Amodiaquine (AQ tablet) (153mg base) Children aged 12–59 months will receive a full tablet as a single daily dose for 3 consecutive days. Children aged 5-14 years will receive two tablets as a single dose for 3 consecutive days. Albendazole (ALB tablet) (200 or 400 mg depending on age) Children aged 12-24 months will receive a half tablet of albendazole 200mg Children aged greater than 2 years and up to 14 years will receive a single dose of albendazole 400mg Praziquantel (PZQ tablet) (600mg) Children aged 1-14 years will receive praziquantel based on their body weight 40mg/kg The following drug will be administered to the children on a monthly basis for four consecutive months as described below: Sulphadoxine-pyrimethamine (SP tablet) (500mg + 25mg) Children aged 12–59 months will receive a full tablet as a single dose on the first day. Children aged 5-14 years will receive two tablets as a single dose on the first day. Amodiaquine (AQ tablet) (153mg base) Children aged 12–59 months will receive a full tablet as a single daily dose for 3 consecutive days. Children aged 5-14 years will receive two tablets as a single dose for 3 consecutive days. The intervention drugs are standard drugs approved by the World Health Organisation for the preventive treatment of malaria (sulphadoxine-pyrimethamine and amodiaquine), schistosomiasis (praziquantel) and soil-transmitted helminths (albendazole). 600
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 written informed consent by the parent/caregiver and a positive assent by children aged ≥ 7 years (in line with legal regulations in Ghana); • Willingness to provide finger prick blood samples, urine, and stool samples; • Residence in the study area for at least the past six months and willingness to be available in the study area for follow-up about 6 months after enrolment. • Acutely ill child at the time of the drug administration; • A child whose parents/care-givers decline to provide consent; • A known HIV-positive child receiving co-trimoxazole prophylaxis; • A child who has received a dose of either Sulphadoxine-pyrimethamine (SP), amodiaquine (AQ), albendazole (ALB) or praziquantel (PZQ) during the previous six months; • A child with a known allergy to any of SP, AQ, ALB, or PZQ Child: 6 Year-12 Year,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
No 17/11/2023 London School of Hygiene Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 06/10/2023 Kintampo Health Research Centre Institution Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kintampo, Bono East Region Kintampo 233001 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/11/2023 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Dodoo Lane, Osu Accra 233001 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in Haemoglobin (Hb) concentration, measured by HemoCue®, On the day of inclusion, at subsequent findings and post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.
Secondary Outcome • Incidence of clinical malaria, defined as fever of >37.5oC or a history of fever in the preceding 48 hours, and a positive malaria blood film with a parasite density of >0 per µl, detected by passive case detection during the surveillance period. • Change in prevalence of anaemia on the day of inclusion, at subsequent findings and post-intervention at the end of malaria transmission season; anaemia will be defined as Hb less than 11 g/dl. • The incidence of solicited adverse events and adverse drug reactions assessed to be related to the study medications during a period of six consecutive days after administration of study drugs. • Prevalence and density of P.falciparum infection; prevalence and density of helminth infection; and prevalence and density of malaria-helminth co-infection On the day of inclusion, at subsequent findings and post-intervention at the end of malaria transmission season i.e. one month after the last SMC cycle.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kintampo Health Research Centre Kintampo North Municipality, Bono East Region, P. O. Box 200, Kintampo Kintampo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
UK Research and Innovation Polaris House, North Star Avenue, Swindon London SN2 1FL 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
Kintampo Health Research Centre Hospital Road, Kintampo North Municipal Kintampo 233001 United Kingdom
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 Associate Professor London School of Hygiene Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Kwaku Poku Asante kwakupoku.asante@kintampo-hrc.org +233352097602 Hospital Road, Kintampo North Municipal, Bono East Region
City Postal code Country Position/Affiliation
Kintampo Ghana Director Kintampo Health Research Centre
Role Name Email Phone Street address
Public Enquiries Dennis AduGyasi Dennis.Adu-Gyasi@kintampo-hrc.org +233207028698 Hospital Road, Kintampo North Municipal, Bono East Region
City Postal code Country Position/Affiliation
Kintampo Ghana Project Coordinator
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 Scientific Advisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant data will be shared via publication of the study findings in peer-reviewed journals within 12 months of the study completion date Informed Consent Form,Study Protocol Within 12 months of the study completion date Open access, full data analysis permitted, reasonable written request to the Principal Investigator
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